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Introduction | edentulous, PES | Implant-supported restorations to rehabilitate partially edentulous patients have become a standardized and predictable therapy with high survival and success rates [The Biologically Oriented Dental Preparation Technique (B.O.P.T.) has been proposed as a technique to vertically prepare dental abutments without a finishing line [These concepts have been transferred to implant-supported restorations by designing an implant with a convergent transmucosal neck and abutments without a finishing line (Prama, Sweden & Martina). This concept is in line with a published guideline for the management of the implant restoration, where a subcritical contour as convergent (concave) as possible is recommended [Today, there is a vast variety of tools and techniques to assess the dimensions and the appearance of peri-implant soft tissues. Several indices have been proposed, such as the pink esthetic score (PES) (14) or the PES and white esthetic score (PES/WES) [Therefore, the aim of the present randomized clinical trial was to evaluate the efficacy of tissue-level implants with a convergent transmucosal neck and abutments without a finishing line on marginal bone levels (MBLs) and soft tissue dimensions changes 12 months after loading and compare it to conventional bone-level implants with abutments with a horizontal finishing line (Fig. CONSORT flow diagram | PMC10264266 | |
Material and methods | PMC10264266 | |||
Study design | The study was designed as a randomized controlled clinical study with a parallel group design and a 12-month follow-up. The proposed null hypothesis was that there would not be differences in terms of MBL changes or soft tissue dimensions changes between two implants with different neck configurations 1 year after loading. The clinical study protocol was approved by the Ethics Committee of the Hospital Clinic San Carlos in Madrid (C.P.-C.I. 14/532-P) and followed the ethical principles founded in the Declaration of Helsinki. The protocol was registered in ClinicalTrials.gov (identifier NCT05051839). All patients gave their written informed consent and accepted to take part of the clinical trial. | PMC10264266 | ||
Subject population | bleeding, periodontitis, PD, tooth, bruxism, diabetes | BLEEDING, PERIODONTITIS, DEHISCENCES, PLAQUE, DIABETES | Consecutive patients were selected from those attending the Postgraduate Clinic in Restorative Dentistry based in the New Technologies, University Complutense of Madrid. The screening examination included the following:Cone-beam CT to determine the bone availability for dental implants.Clinical examination to evaluate the patient inclusion and exclusion criteria.Standardized intraoral photographs for registering the baseline site status.Patients were selected based on the following criteria.Inclusion criteriaMale or female ≥ 18 years old.Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge). Free-ended situations without a distal tooth were allowed.Bone quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama implants (Due Carrare, Padova, Italy) with diameters between 3.8 and 5 mm (mm) and lengths between 10 and 13 mm.Healthy ASA type I and II patients.Full-mouth plaque index < 20% (percentage of sites with plaque measured at 6 sites per tooth in every tooth of the mouth).Presence of ≥ 2 mm of keratinized mucosa at the buccal and lingual portion of the implant.Exclusion criteriaSmokers ≥ 10 cigarettes/day.Presence of implant-supported restorations adjacent to the study site.Active periodontitis defined as the presence of pockets with probing depth (PD) ≥ 5 mm and bleeding on probing (BoP).Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).Uncontrolled diabetes (HbA1c > 7.5).Severe bruxism.Pregnancy.Previous history of radiotherapy.Exclusion criteria at surgeryVertical soft tissue thickness < 2 mm assessed with a periodontal probe after placing anesthesia at the mid crestal portion of the edentulous site.Lack of primary stability defined as < 10 Ncm measured by hand torque wrench.Need of augmentation procedures in the presence of dehiscences or fenestrations.Unable to place the implant according to the prosthetic requirements. | PMC10264266 |
Study groups | Figure Test and control group implant design. In the left, the test group (Prama, Sweden and Martina), and in the right, the control group (Premium, Sweden and Martina). The implant design characteristics: | PMC10264266 | ||
Control group ( | Patients in the control group received bone-level implants with a 0.8 mm height straight and machined rim and a 3.4 mm internal hex prosthetic connection (Premium SP, Sweden & Martina). In the restoration phase, titanium abutments with a straight emergence from the implant head and a horizontal finish line were used. | PMC10264266 | ||
Test group ( | Patients in the test group received tissue-level implants with a 2.8 mm convergent transmucosal neck and an ultrathin threaded microsurface (UTM). The first portion consisted of a 0.8 mm height straight neck followed by a hyperbolic convergent portion of 2 mm height. The prosthetic connection was an internal hex of 3.4 mm (Prama, Sweden & Martina). In the restoration phase, titanium abutments without a finish line and a continuous surface with the convergent transmucosal neck were used following the B.O.P.T. philosophy. | PMC10264266 | ||
Surgical phase | All surgeries were performed by two experienced and calibrated specialists in dental implantology (GP and IS). All patients followed the same surgical protocol under local anesthesia with articaine 4% and adrenalin (1:100.000). A mid-supracrestal incision was made including the adjacent teeth, and a full-thickness mucoperiosteal flap was raised. Implant sites were prepared following the manufacturer’s instructions. Sealed envelopes were opened. The implant insertion was the same for both the test and control groups. The 0.8 mm straight section of the machined rim in the control implants and the ultrathin threaded microsurface in the test implants were submerged at the level of the crestal bone. In the test group, the hyperbolic neck portion was not submerged (Fig. Convergent transmucosal neck implant placement surgery. Test group. (Prama, Sweden and Martina, Italy) | PMC10264266 | ||
Restorative phase | Twelve weeks after surgeryTest group final restorations: Control group final restoration: | PMC10264266 | ||
Measurements and outcome variables | The primary outcome of the present RCT was the change on MBLs between baseline and 12 months. MBLs were calculated by measuring the distance from the implant shoulder to the first visible bone-to-implant contact at the mesial and distal aspect of each implant (Fig. Baseline standardized periapical radiograph on the day of cementation in the study group | PMC10264266 | ||
Secondary outcomes | PMC10264266 | |||
Linear soft tissues dimensions | The soft tissues contour measurements were performed using digital impressions taken at baseline and at the 12-month follow-up visit, which were uploaded into a software (OraCheck, Cyfex, Switzerland) to analyze the changes in the soft tissue dimensions. Both files were superimposed using a best-fit algorithm to obtain an overlap with the smallest possible discrepancy. The implant-supported restorations, the adjacent mesial and distal teeth, and its keratinized gingiva were selected for the analysis with the selection tool (Fig. Horizontal linear measurement at the level of the initial mucosal margin. The difference between both measurements represents the change in contour thickness at the most coronal portion.Horizontal linear measurement 2 mm apical to the initial mucosal margin. The difference between both measurements represents the change in contour thickness 2 mm apical to the position of the mucosal margin at baseline.Mucosal recession was assessed by measuring the vertical distance between the position of the mucosal margin at the different time points.The volume was analyzed with a color-coded graph in µm, which corresponds to the mean distance between the two surfaces within the analyzed area of interest (implant and adjacent teeth). The yellow, orange, red, and pink colors represent an increased distance, which is equivalent to an increase in tissue contour thickness. Those areas in blue and violet color indicated a loss in thickness. A color-coded scale ranging from + 500 to − 500 µm was selected.Graphic image of the analysis of the distance between the digital casts with the color code in a case of the study group (OraCheck, Cyfex, Switzerland)Diagram of the horizontal measurements: (1) Horizontal measurement from the basal gingival margin at the same height in the follow-up scan (difference in thickness at the gingival margin). (2) Horizontal measurement 2 mm apical from the baseline gingival margin at the same height in the follow-up scan (difference in thickness at 2 mm from gingival margin). (3) Vertical measurement from the inflection point between the crown curvature and the peri-implant soft tissue to that same point of the follow-up scan (height difference of the gingival margin) (OraCheck, Cyfex, Switzerland) | PMC10264266 | ||
Peri-implantitis | suppuration, bone loss | SUPPURATION, BONE LOSS | It is defined as the presence of BOP and/or suppuration together with increased probing pocket depth and radiographic bone loss > 2 mm during the first year after loading [ | PMC10264266 |
Statistical analysis | bone loss | BONE LOSS | The sample size was calculated for detecting a mean difference between test and control groups in radiographic marginal bone level changes of 1 mm with a standard deviation (SD) of 1.25 mm, an alpha error of 0.05, and a statistical power of 80% (G*Power 3.1 Software). After a pilot study with 10 patients comparing both groups with a mean marginal bone loss in the test group of 1.25 ± 1.25 mm and in the control group of 2.37 ± 0.69 mm, the resulting sample size was 28. Each patient was randomized to receive one of the two types of implants by means of a computer-generated random list and by blocks of four treatments each. Allocation concealment was assured using opaque sealed envelopes that were opened immediately after implant site preparation.Descriptive statistics (mean values, standard deviations, medians, and 95% confidence intervals) of variables were performed for each group using a statistical software program (SPSS version 25.00; IBM, USA). The implant was considered the unit of analysis. The normality was assessed by means of a Kolmogorov–Smirnov test and was found to be normally distributed. The | PMC10264266 |
Results | PMC10264266 | |||
Patient population and follow-up | Twenty-five patients with 38 implants were included in the study and received surgery (Table Baseline demographic characteristics of the study sample | PMC10264266 | ||
Marginal bone level changes | Table Marginal bone level changes at 12-month follow-up at millimeters (mm) | PMC10264266 | ||
Linear soft tissues contour measurements | The linear increase in buccal soft tissue contour thickness at the level of the mucosal margin was greater in the test (1.96 ± 2.69 mm) than in the control group (0.65 ± 0.42 mm), although this difference was not statistically significant. Two mm apically to the buccal mucosal margin, the increase was minimal and similar in both groups (Table Linear soft tissues contour changes at 12-month follow-up in millimeters. (GM, gingival margin) | PMC10264266 | ||
Discussion | bone loss, peri-implantitis | BONE LOSS | The results from the present randomized clinical trial have shown that both types of implants were associated with stable marginal bone levels and an improvement in the soft tissue contour. Both groups showed minimal bone loss 1 year after loading (0.16 mm in the test group and 0.45 mm in the control group). However, no statistically significant differences were detected when comparing the convergent and the straight implant neck.These results are comparable to those published by Agustín-Panadero et al. 2019 [The convergent transmucosal neck presents a similar philosophy to the platform switching concept. The idea is to give the soft tissue a greater horizontal space and to shift coronally the implant-abutment connection, which at the same time could prevent bone remodeling by providing a better sealing [It should be noted that peri-implantitis developed fast and it was greater in the test group (3 implants in the test and 1 implant in the control). This is in agreement with the study by Derks et al. that showed that the onset of peri-implantitis occurred early [In the present study, we have observed a greater increase in soft tissue contour thickness around the convergent transmucosal neck (1.96 ± 2.69 mm) than in the conventional bone-level implant (0.65 ± 0.42 mm). However, this difference has not been statistically significant. Similar results around the convergent transmucosal neck have been reported in a recent case series, showing that these implants, together with crowns using the B.O.P.T. philosophy, experienced a significant increase in soft tissue thickness, both at the buccal (0.56 ± 0.46 mm) and at the lingual (0.33 ± 0.45 mm) surfaces 10 months after prosthetic loading [Different esthetic parameters have been reported when using implants with a convergent transmucosal neck. In the prospective study published by Patri et al. 2017 [Several studies have shown that the most frequent pattern was the apical migration of the mucosal margin [There is a great heterogeneity in the parameters and methods used to evaluate the esthetics and the volume of the peri-implant soft tissues [ | PMC10264266 |
Author contribution | This study is signed by five authors due to its contribution to the study conception and design. Material preparation and data collection were performed by Maria Paz Salido and Francisco Martinez-Rus. The formal analysis was performed by Ignacio Sanz-Sanchez and Belen Moron-Conejo. The first draft of the manuscript Belen Moron-Conejo was written by and reviewed and edited by Ignacio Sanz-Sanchez and Guillermo Pradies. | PMC10264266 | ||
Funding | Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. This project was partially supported by Sweden & Martina. | PMC10264266 | ||
Data availability | The research data is available through contact with the corresponding author and is registered at the Complutense University of Madrid. | PMC10264266 | ||
Declarations | PMC10264266 | |||
Ethical approval and consent to participate | All procedures performed in the present study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declarations and its later amendments or comparable ethical standards.The clinical study protocol was approved by the Ethics Committee of the Hospital Clinic San Carlos in Madrid (C.P.-C.I. 14/532-P) and followed the ethical principles founded in the Declaration of Helsinki. The protocol was registered in ClinicalTrials.gov (identifier NCT05051839). Informed consent was obtained from all individual participants included in the present study. They were informed verbally and in writing of the advantages and disadvantages of participating in the study. | PMC10264266 | ||
Consent for publication | This manuscript has not been published and is not in consideration for publication elsewhere. All authors have approved the manuscript, agreed with its submission, and given their consent for publication. | PMC10264266 | ||
Competing interests | The authors declare no competing interests. | PMC10264266 | ||
References | PMC10264266 | |||
Key Points | PMC10394571 | |||
Question | Is dural-puncture epidural (DPE) superior to standard epidural when used for conversion to surgical anesthesia in patients undergoing elective cesarean delivery? | PMC10394571 | ||
Findings | In this randomized clinical trial of 140 participants, the onset time to surgical anesthesia was faster in the DPE group compared with the standard epidural group (422 vs 655 seconds). | PMC10394571 | ||
Meaning | These results suggest that DPE epidural extension anesthesia is superior to standard epidural, but these findings need to be confirmed in women requiring intrapartum cesarean delivery.This randomized clinical trial examines the effect of dural-puncture epidural vs standard epidural for epidural extension on onset time of surgical anesthesia in individuals undergoing elective cesarean delivery. | PMC10394571 | ||
Importance | Dural-puncture, neuraxial labor | LITTLE | Dural-puncture epidural (DPE) and standard epidural are common modes of neuraxial labor analgesia. Little is known about conversion of DPE-initiated labor analgesia to surgical anesthesia for cesarean delivery. | PMC10394571 |
Objective | To determine whether DPE provides a faster onset and better-quality block compared with the standard epidural technique for cesarean delivery. | PMC10394571 | ||
Design, Setting, and Participants | This double-blind, randomized clinical trial was conducted between April 2019 and October 2022 at a tertiary care university hospital (University of Arkansas for Medical Sciences). Participants included women aged 18 years and older undergoing scheduled cesarean delivery with a singleton pregnancy. | PMC10394571 | ||
Interventions | Participants were randomized to receive DPE or standard epidural in the labor and delivery room. A T10 sensory block was achieved and maintained using a low concentration of bupivacaine with fentanyl through the epidural catheter until the time of surgery. Epidural extension anesthesia was initiated in the operating room. | PMC10394571 | ||
Main Outcomes and Measures | T6 sensory block | SECONDARY | The primary outcome was the time taken from chloroprocaine administration to surgical anesthesia (T6 sensory block). The secondary outcome was the quality of epidural anesthesia, as defined by a composite of the following factors: (1) failure to achieve a T10 bilateral block preoperatively in the delivery room, (2) failure to achieve a surgical block at T6 within 15 minutes of chloroprocaine administration, (3) requirement for intraoperative analgesia, (4) repeat neuraxial procedure, and (5) conversion to general anesthesia. | PMC10394571 |
Results | Among 140 women (mean [SD] age, 30.1 [5.2] years), 70 were randomized to the DPE group, and 70 were randomized to the standard epidural group. The DPE group had a faster onset time to surgical anesthesia compared with the standard epidural group (median [IQR], 422 [290-546] seconds vs 655 [437-926] seconds; median [IQR] difference, 233 [104-369] seconds). The composite rates of lower quality anesthesia were 15.7% (11 of 70 women) in the DPE group and 36.3% (24 of 66 women) in the standard epidural group (odds ratio, 0.33; 95% CI, 0.14-0.74; | PMC10394571 | ||
Conclusions and Relevance | Anesthesia initiated following a DPE technique resulted in faster onset and improved block quality during epidural extension compared with initiation with a standard epidural technique. Further studies are needed to confirm these findings in the setting of intrapartum cesarean delivery. | PMC10394571 | ||
Trial Registration | ClinicalTrials.gov Identifier: | PMC10394571 | ||
Introduction | labor | SECONDARY | Neuraxial analgesia is considered the criterion standard for labor and delivery, with an estimated 71% of parturients in the US receiving some form of neuraxial analgesia.The DPE technique is similar to the combined spinal-epidural technique but without the injection of intrathecal drugs. First, the epidural space is identified with an epidural needle, and then a spinal needle is inserted through the epidural needle to puncture the dura. After confirmation of clear cerebrospinal fluid, the spinal needle is then removed, and the epidural catheter is inserted to initiate analgesia. The hypothesized advantage of the DPE over the standard epidural technique is improved analgesia secondary to epidural midline placement through the confirmation of cerebrospinal fluid flow through the spinal needle. Dural puncture with a DPE may also facilitate translocation of epidural medications into the intrathecal space to improve analgesia.In view of the increasing use of DPE and its proposed advantages for labor analgesia, we conducted a double-blind, randomized clinical trial (RCT) to determine whether the DPE technique is superior to the standard epidural when used for epidural extension anesthesia in parturients undergoing elective cesarean delivery. We hypothesized that DPE would provide faster onset of surgical anesthesia compared with the standard epidural technique. We also sought to determine whether DPE would improve the overall quality and reliability of epidural anesthesia. | PMC10394571 |
Methods | allergy, scoliosis, fetal anomalies | ALLERGY, SCOLIOSIS | This single-center, double-blind, RCT was approved by the institutional review board at the University of Arkansas for Medical Sciences and was conducted between April 2019 and October 2022. This article adheres to the applicable Consolidated Standards of Reporting Trials (The authors recognize that there is a gender spectrum; however, all participants identified as women in this study, so we use this term throughout. We enrolled women with singleton pregnancies and American Society of Anesthesiologists physical status II or III who were scheduled for elective cesarean delivery. Participants were excluded if they were younger than 18 years, weighed more than 120 kg, were less than 150 cm tall, were unable to understand English, and had contraindications to neuraxial anesthesia, previous back surgery or scoliosis, severe fetal anomalies, or allergy to any study medications. Race and ethnicity were self-reported by the participants (Black, White, or other, which includes Asian, Hispanic ethnicity, and any other race or ethnicity not otherwise specified) and were included to assess the representativeness of the sample being studied.After providing written informed consent, participants were randomly assigned to receive either standard epidural or DPE. A computer-generated, 1:1 ratio randomization schedule with blocks of 10 was created by a research coordinator not involved in the study. Allocation assignments remained concealed using sequentially numbered, opaque, sealed envelopes. Before scheduled cesarean delivery, the proceduralist opened the envelope containing the group allocation. Epidural procedures were performed by the attending anesthesiologist or by residents under direct supervision of the attending anesthesiologist. The team performing the epidural technique had no other involvement in the study. The clinical team caring for the patient (obstetricians, anesthesiologists, and nurses), outcome assessors, data analyst, and study participants were blinded to randomization. A blinded investigator (N.S. or M.W.) assessed all perioperative outcomes. | PMC10394571 |
Epidural Placement | As described in a prior study, | PMC10394571 | ||
Protocol for Epidural Extension Anesthesia | pain | A blinded investigator (N.S. or M.W.) confirmed that participants had at least a bilateral T10 sensory level preoperatively. Alternative neuraxial anesthesia was offered if the block had not reached a T10 level. Participants were then transferred to the operating room, and routine monitoring was reapplied. The sensory and motor block were assessed according to the Modified Bromage score.Epidural extension anesthesia was standardized on the basis of institutional practice. A co-load of lactate ringers solution (500 mL) was given intravenously over approximately 15 minutes. After confirming negative aspiration of the epidural catheter, a test dose of 5 mL of 3% chloroprocaine was given, and the patient was monitored for signs of accidental intrathecal injection. If no abnormal signs were observed after 3 minutes, a further 15 mL of 3% chloroprocaine was injected over approximately 1 minute. The start of this injectate was defined as time zero and the beginning of epidural extension. A blinded investigator (N.S. or M.W.) assessed the block at 1-minute intervals, initially moving from a caudal to a cranial direction and then more frequently as the block ascended. A Neurotip (Owen Mumford) provided a standardized sharp-pain stimulus.If a T6 bilateral block was not achieved within 10 minutes after the start of epidural extension, then 5-mL aliquots of epidural 3% chloroprocaine were administered every 5 minutes up to a total maximum cumulative dose of 30 mL. If the block did not reach a T6 level within 20 minutes, the attending anesthesiologist provided a different anesthetic technique according to clinical discretion. A phenylephrine infusion was started at 25 µg per minute, and the dose was titrated to maintain systolic blood pressure within 15% of preoperative baseline.Intraoperatively all patients received intravenous cefazolin (2 g), dexamethasone (4 mg), ondansetron (4 mg), and ketorolac (30 mg) in the absence of contraindications. After delivery of the infant, an intravenous oxytocin infusion was commenced, and 3 mg of epidural morphine was administered for postoperative analgesia, followed by oral acetaminophen (650 mg every 6 hours), ibuprofen (600 mg every 6 hours), and oxycodone (5-10 mg every 4 hours) for breakthrough pain as required. | PMC10394571 | |
Outcomes | PDPH, hand weakness, pain, pruritus, headache, accidental dural puncture, nausea, vomiting | ADVERSE EVENTS, EVENT, LOCAL ANESTHETIC SYSTEMIC TOXICITY, SECONDARY | The primary outcome was the onset time to surgical anesthesia. This was defined as the start of epidural extension anesthesia (time zero on the stopwatch) to when the patient could no longer feel sharp sensation at T6 (assessed bilaterally at the midclavicular line).Secondary outcomes included the quality of epidural anesthesia. This was a composite of the following factors: (1) failure to achieve a T10 bilateral block preoperatively (after epidural administration of 3 mL of 1.5% lidocaine with 1:200 000 epinephrine and up to 20 mL of 0.0625% bupivacaine with 2 µg/mL fentanyl), (2) failure to achieve a surgical block within 15 minutes of epidural extension anesthesia, (3) the requirement for intraoperative analgesia supplementation, (4) requirement for repeat neuraxial procedure, or (5) conversion to general anesthesia. The intraoperative analgesia supplementation rate was defined as the requirement for any rescue medication to control discomfort or pain during cesarean delivery. The choice of medication was at the clinical discretion of the anesthesiologist. All components of the composite outcome were treated as binary measures, and the presence of any event was considered positive for the secondary outcome (collapsed composite).Other secondary outcomes included maternal satisfaction and pain score during surgery (assessed in recovery room, where 0 indicates very dissatisfied and 10 indicates very satisfied), opioid consumption in the first 24 hours, adverse events (eg, self-reporting of nausea, vomiting, or pruritus), timings (from primary outcome to start of surgery and duration of surgery), maternal vasopressor requirements (intraoperative dose administered), epidural block assessments, neonatal outcomes (Apgar score at 1 and 5 minutes and the umbilical cord blood gasses), and other adverse events, including local anesthetic systemic toxicity, accidental dural puncture (ADP), high spinal (ie, exaggerated cranial spread of spinal anesthesia leading to hand weakness, difficulties breathing, and, finally, unconsciousness), and postdural puncture headache (PDPH) assessed on postpartum day 1. | PMC10394571 |
Statistical Analysis | The primary outcome of the study was time to loss of sharp sensation at the T6 level. On the basis of our previous study, | PMC10394571 | ||
Results | Among 256 parturients who were assessed for eligibility, 140 participants (mean [SD] age, 30.1 [5.2] years) were enrolled into the study (70 participants were randomized to each group) ( | PMC10394571 | ||
Study Flow Diagram | PMC10394571 | |||
Demographic and Clinical Characteristics of Participants | Abbreviation: LTCD, low transverse cesarean delivery.Body mass index is calculated as weight in kilograms divided by height in meters squared.Includes Asian, Hispanic ethnicity, and any other race or ethnicity not otherwise specified. | PMC10394571 | ||
Primary Outcome: Onset Time to Surgical Anesthesia | The primary outcome of median (IQR) time to surgical anesthesia was 655 (437-926) seconds in the standard epidural group and 422 (290-546) seconds in the DPE group ( | PMC10394571 | ||
Intraoperative Data, Outcomes, and Adverse Events | intraoperative pain, pain | Abbreviations: BE, base excess; IV, intravenous; NA, not applicable.Data are odds ratio (95% CI).The Bromage score is as follows: 0, no motor block, full flexion of knees and feet; 1, just able to move knees; 2, able to move feet only; and 3, unable to move feet or knees. Median difference is shown.The intraoperative pain scale ranged from 0 (no pain) to 10 (worst pain).Mean difference is shown.The patient satisfaction rating ranged from 0 (extremely dissatisfied) to 10 (extremely satisfied). | PMC10394571 | |
Kaplan-Meier Survival Curves for the Primary Outcome | Kaplan-Meier survival curves for the primary outcome show proportion of patients who did not achieve a sensory blockade level to T6. | PMC10394571 | ||
Secondary Outcomes: Quality of Epidural Anesthesia | For the composite of 5 outcomes indicating lower quality of anesthesia, the observed composite rate was 11 of 70 women (15.7%) in the DPE group compared with 24 of 66 women (36.3%) in the standard epidural group (odds ratio, 0.33; 95% CI, 0.14-0.74; | PMC10394571 | ||
Discussion | The main finding from this RCT is that epidural extension initiated with a DPE has an approximately 3-minute faster onset time to cesarean anesthesia than a standard epidural and a more favorable quality of epidural blockade (18.6% risk reduction) for cesarean delivery. We believe these results are clinically meaningful and relevant for patients requiring emergent cesarean delivery under epidural extension anesthesia. A recent study by Palmer et alAlthough our study demonstrates clear evidence of benefit in women requiring elective cesarean delivery, studies examining labor analgesia have reported inconsistent findings. StudiesThese contradictory results may be due to methodological heterogeneity. The mechanisms determining flux of local anesthetics through the meninges and the hole created by the dural puncture are complex and have not yet been fully elucidated.The physicochemical properties of the local anesthetic may also be an important determinant of transmeningeal diffusion. Chloroprocaine is mostly ionized at physiological pH with an inherently slow diffusion rate. Our study indicates that the flow of chloroprocaine may have been promoted through the dural puncture owing to the rapid administration of a relatively large mass of drug.The differences in umbilical cord base excess between the groups warrant further study, as do the differences in Apgar scores, although they were not significant. This study was underpowered for these outcomes, and the clinical relevance of such findings is questionable because umbilical artery and vein pH values were within normal limits. | PMC10394571 | ||
Limitations | We acknowledge that this study has some limitations. First, and most importantly, the epidural technique was performed in women who were scheduled for elective cesarean delivery and were not in labor. The epidural technique was performed approximately 1 hour before entry into the operating room, and an epidural infusion was used to maintain a T10 sensory level. | PMC10394571 | ||
Conclusions | In the context of our study, a DPE performed within an hour of epidural extension for elective cesarean delivery was associated with a faster onset of anesthesia, improved block quality, and a favorable risk-to-benefit ratio compared with standard epidural. Further studies are needed to investigate whether these findings can be validated in the clinical context of intrapartum cesarean deliveries, whether these benefits persist with different local anesthetic mixtures and timings from DPE to epidural extension, and to confirm neonatal outcomes. | PMC10394571 | ||
References |
Trial Protocol
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Data Sharing Statement
Click here for additional data file. | PMC10394571 | ||
Abstract | Editor: Linda WangConflict of interestThe authors declare no conflict of interest. | PMC10343945 | ||
Objective | This clinical study aimed to evaluate the clinical performance of an alkasite-based bioactive material by comparing it with a resin composite (RC) in the restoration of Class II cavities over a year. | PMC10343945 | ||
Methodology | POSTERIOR | A hundred Class II cavities were restored at 31 participants. Groups were as follows: Cention N (CN) (Ivoclar Vivadent, Schaan, Liechtenstein) and G-ænial Posterior (GP) (GC, Tokyo, Japan) in combination with G-Premio Bond (etch&rinse). Restorative systems were applied following manufacturers’ instructions. They were finished and polished immediately after placement and scored based on retention, marginal discoloration, marginal adaptation, sensitivity, surface texture, and color match using modified USPHS criteria after 1 week (baseline), 6 months, and 12 months. Statistical analyses were performed using chi-square, McNemar’s, and Kaplan Meier tests. | PMC10343945 | |
Results | caries | SECONDARY, CARIES | After 12 months, the recall rate was 87%. Survival rates of CN and GP restorations were 92.5% and 97.7%, respectively. Three CN and one GP restorations lost retention. Seven CN (17.9%) and five (11.6%) GP restorations were scored as bravo for marginal adaptation and no significant difference was seen between groups (p=0.363). One (2.7%) CN and two GP (4.7%) restorations were scored as bravo for marginal discoloration, but no significant difference was observed between groups(p=1.00). For surface texture, three (8.1%) CN and three (7%) GP restorations were scored as bravo (p=1.00). None of the restorations demonstrated post-operative sensitivity or secondary caries at any examinations. | PMC10343945 |
Conclusion | The tested restorative materials performed similar successful clinical performances after 12 months. ClinicalTrials.gov (NTC04825379). | PMC10343945 | ||
Introduction | caries | CARIES, PLAQUE | High plaque accumulation at the proximal surfaces of posterior teeth can lead to the development of caries and the necessity of dental treatments.The alkasite-based tooth-colored material Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) is considered integrant of a subgroup of RCs. This self-curing restorative, with optional additional light curing, displays a high polymer network density and degree of polymerization over the complete depth of the restoration.Several studies have demonstrated that this alkasite-based material releases acceptable levels of fluoride, calcium, and phosphate.Although several | PMC10343945 |
Methodology | The Consolidated Standards of Reporting Trials (CONSORT) statement was followed to design the study. | PMC10343945 | ||
Ethics approval | The Ethics Committee of the institution approved the present clinical trial (KA-21046) and informed consent forms were taken from participants. | PMC10343945 | ||
Protocol registration | The study was registered at ClinicalTrials.gov (NTC04825379). | PMC10343945 | ||
Trial design and setting | This randomized, double-blind, controlled clinical trial was performed at the Department of Restorative Dentistry clinic. | PMC10343945 | ||
Sample size calculation | Power analysis using G* Power statistical software (ver. 3.0.10, Franz Faul, Universitat Kiel, Germany) was used to calculate the sample size. To achieve an w = 0.50 effect difference between the groups with 90% power and an alpha error of 5%, at least 26 restorations per group were needed. Considering the possibility of dropouts during follow-up, the sample size was increased to at least 50 in each group, and a total of 100 restorations were performed. | PMC10343945 | ||
Patient selection | Thirty-one patients with an average age of 33 years who fulfilled the inclusion and exclusion criteria were selected (
| PMC10343945 | ||
Inclusion and exclusion criteria for participants | PMC10343945 | |||
Randomization | Each patient received at least two restorations. Computer-generated tables were used to randomize restorative systems. A number was assigned to each restorative system in the tables for patient allocation. Only a researcher who was not involved in the study could access the tables. | PMC10343945 | ||
Restorative procedures | Diamond fissure, carious, pain | POSTERIOR, CAVITY | One hundred restorations were placed in Class II cavities of 31 patients (17 males, 14 females) with an average age of 33 years. One week before the restorative procedures, dental prophylaxis was performed on participants and oral hygiene instructions were provided. All restorations were performed by the same researcher, who did not participate in the selection of study individuals. Teeth were cleaned with a slurry of pumice before preparations. Diamond fissure burs at high speed were used under water-cooling for preparations, whereas tungsten carbide burs with slow speed handpiece were used to remove carious tissues. If the patient felt pain or sensitivity, local anesthesia was applied. Tissue preserving cavity design was applied and the prepared cavities did not involve any cusps; additionally, the gingival walls were located supra gingivally. The cavities which did not meet these criteria were excluded. In deep cavities, a calcium hydroxide cavity liner (Life Regular Set, Kerr Corporation, Romulus, MI, USA) was placed. A sectional matrix was used before the application of restoratives. The teeth were restored either with an alkasite-based restorative (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein [CN]) (n=50) or a RC (G-ænial Posterior GC, Tokyo, Japan [GP]) (n=50). Cotton rolls and saliva ejectors were used for isolation. The restorative materials used are shown in Table 2. Cention N was used without prior application of an adhesive system. Both restorative material systems were applied according to the manufacturers’ recommendations (
| PMC10343945 |
Applications of materials used in the study | Methacryloyloxydecyl dihydrogen | POSTERIOR | MDP: 10-Methacryloyloxydecyl dihydrogen phosphate, Bis-GMA: Bisphenol A diglycidylmethacrylate, HEMA: 2-Hydroxyethyl methacrylate, BHT: Butylated hydroxytoluene, MDTP: Methacryloyloxydecyl dihydrogen thiophosphateEach increment of the RC (G-ænial Posterior) was light-cured for 40 seconds (at 1200 mW/cm | PMC10343945 |
Clinical assessments | ’s Q | Patients were called for controls after 1 week (baseline) and 6 and 12 months. The restorations were evaluated for the retention, marginal adaptation, marginal discoloration, surface texture, color match, and post-operative sensitivity according to the United States Public Health Service (USPHS) criteria.Two researchers who were blinded to the group assignments and not involved in the clinical procedures evaluated the restorations. Ten representative photographs for each criterion were used to calibrate the researchers. Then, researchers assessed 10–15 restorations at two consecutive appointments. Intra- and inter-examiner agreement of at least 85% was necessary to begin the evaluation. Subjects were not informed about the group assignments either.SPSS software (version 22.0; IBM Corp., Armonk, NY, USA) was used for statistical analyses. To compare the restorative materials, Pearson chi-square tests were conducted at each recall. Differences in the ratings of the two materials were assessed at 6 and 12 months. Cochran’s Q test was used to examine the changes over time for each material. McNemar’s test was used to compare the marginal adaptation, discoloration, and surface texture scores of each material with their baseline scores across various time points. Additionally, Kaplan-Meier analysis was performed to compare the survival rates of the restorations. The level of significance was set at p < 0.05. | PMC10343945 | |
Results | The flow chart was shown in
| PMC10343945 | ||
Flow diagram of the study | PMC10343945 | |||
Clinical evaluation outcomes of different restorations | ’s Q, caries, restorations lost retention | SECONDARY, CARIES | sIndicates significant difference in comparison with baseline according to Cochran’s Q test fallowed by McNemar's test (p<0.05) CN: Cention N, GP: G-ænial PosteriorThe outcomes were scored as alpha: clinically very good, bravo: clinically good, acceptable, charlie: clinically unacceptableOne (3%) CN restoration lost retention after 6 months, and two (5.1%) CN and one (2.3%) GP restorations lost retention at 12-month evaluations.Additionally, eight CN (17%) and 1 GP (2%) restorations exhibited bravo scores for marginal adaptation after 6 months and McNemar’s test exhibited changes in marginal adaptation in CN at 6 -month recall (p=0.016). CN showed significantly higher bravo scores than GP (p=0.015). After 12 months, 7 CN (17.9%) and 5 (11.6%) GP restorations were scored as bravo and no significant difference was seen between the groups (p=0.363). Four patients could not attend to the 12-month recall and 1 patient with a bravo score was among them. Both groups showed significant changes in marginal adaptation after 12 months (p=0.004, p=0.019).One (2.1%) CN restoration showed bravo score, whereas all GP restorations were scored as alpha for marginal discoloration at 6-month examinations. At 12-month recall, 1 (2.7%) CN and 2 GP (4.7%) restorations were scored as bravo. However, no statistically significant difference was detected between groups after 12 months (p=1.00).For surface texture, 3 (6.4%) CN and 1 (2.0%) GP restorations showed bravo scores at 6-month evaluations (p=0.357) whereas, 3 (8.1%) CN and 3 (7%) GP restorations were scored as bravo at 12-month recall (p=1.00).In terms of color match, 2 (9.1%) CN restorations showed bravo scores at 6-month examinations. At 12-month recall, 3 (8.1%) CN and 1 (2.7%) GP restorations exhibited bravo scores (p=0.658), but no significant difference was seen between the groups at any evaluation point.No post-operative sensitivity or secondary caries were seen at any recall assessment.The Kaplan–Meier analysis (
| PMC10343945 |
Survival curves for tested groups (CN [Cention N], GP [G- ænial Posterior]) | PMC10343945 | |||
Discussion | caries lesions, non-carious cervical lesions, caries, tooth | POSTERIOR, CAVITY, CARIES | New approaches in restorative materials were focused on the development of self-adhesive, dual-cured restorative materials that can be placed in bulk to simplify the placement of posterior restorations and have caries-protecting properties. The self-cure option leads to better depth of cure and these materials also have bioactive characteristics such as leaching remineralizing ions.Although several The only clinical trial published on the clinical performance of CN was in the restoration of non-carious cervical lesions by comparing it with a RMGIC.In the present study, CN showed similar retention rate with the RC in 1-year follow-up. However, the marginal adaptation scores of CN significantly worsened after 6 months and RC showed statistically higher alpha scores than CN. On the other hand, the bravo scores of both groups were similar after one year.After removing caries lesions in the proximal surfaces, the environment becomes less cariogenic, affecting the neighboring tooth as well. The ion-leaching restorative material can help to reduce bacterial growth and promote the formation of fluorohydroxyapatite in proximal caries lesions.Posterior RCs are desired by patients for esthetic reasons and preferred by the dentists for their advantages such as the superior protection of hard tissues with a conservative cavity preparation and cheaper price compared to porcelain restorations. Bulk-fill RCs have been used very often recently for their short application time and ensured deep polymerization.The introduction of alkasite-based restorative material was connected with the hope of replacing amalgam. Therefore, CN could be a more reliable restorative material in minimal intervention oral care based adhesive systems. To improve its mechanical properties, several attempts are still underway. Recently, a manageable self-mixing capsule has been developed for reassessment of the material properties; however, opportunities for improvement are still existing.This study has some limitations that must be considered. Firstly, the short evaluation period. This study is a preliminary report and the evaluation period is not long enough. However, no clinical data on this material has been available to date. Therefore, studies examining the restoration of Class II cavities with longer follow-ups are needed. Secondly, this study included individuals with healthy periodontal tissues and, thus, studies with different participants should be performed in the future.Lastly, in this study, cotton rolls were used for isolation to imitate clinical conditions. A meta-analysis study by Heintze, et al. | PMC10343945 |
Conclusion | Clinical performances of the alkasite-based restorative and resin composite were similar and both materials showed a good survival after 12 months.Data availability statementThe datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10343945 | ||
References | PMC10343945 | |||
Background | Peripheral nerve block | Peripheral nerve block, including the quadratus lumborum block (QLB), has been used for postoperative analgesia in hip surgery. However, the effects of QLB on cognitive function after hip surgery remain unknown. This study aimed to assess the effects of the anterior approach to QLB on postoperative cognitive function in older people undergoing hip surgery. | PMC10712103 | |
Methods | POCD, postoperative cognitive dysfunction | MAY, ADVERSE EFFECTS | Sixty older people who underwent hip surgery from May 2021 to May 2022 were randomly divided into the QLB (n = 30) and control groups (n = 30). The Montreal Cognitive Assessment (MoCA) score (mean ± SD) was measured one day preoperatively and seven and 30 days postoperatively. The frequency (%) of postoperative cognitive dysfunction (POCD) was examined seven and 30 days postoperatively. The visual analog scale (VAS) scores at rest and Bruggrmann comfort scale (BCS) scores [Median (IQR)] 6 h (t1), 12 h (t2), 24 h (t3), and 48 h (t4) after surgery were assessed. The plasma high mobility group box protein 1 (HMGB1) and levels of interleukin-6 (IL-6) (mean ± SD) were evaluated 1 h preoperatively (baseline) and 24 h postoperatively (day 1). The requirement for rescue analgesia [Median (IQR)], time to first off-bed activity (mean ± SD), and adverse effects after surgery were also recorded. | PMC10712103 |
Results | POCD | Compared with the control group, the frequency of POCD was significantly lower in the QLB group seven days postoperatively (10.7% vs. 34.5%, | PMC10712103 | |
Conclusions | ANTERIOR | Anterior QLB given to older people undergoing hip surgery could promote early postoperative cognitive function recovery, provide adequate postoperative analgesia, and inhibit the release of inflammatory factors. | PMC10712103 | |
Keywords | PMC10712103 | |||
Background | postoperative pain, fractures, quadratus lumborum block, a trunk nerve block | COMPLICATIONS, OSTEOPOROSIS | Hip fractures are more common in older people due to osteoporosis. It is estimated that around six million patients worldwide will suffer hip fractures annually by 2050 as the population ages [Based on the expert consensus of the Chinese Association of Anesthesiologists, multimodal analgesia is recommended to alleviate postoperative pain, reduce complications, and improve postoperative recovery quality. As a trunk nerve block, quadratus lumborum block (QLB) has been widely used for postoperative analgesia in patients undergoing abdominal and lower limb surgeries [ | PMC10712103 |
Methods | postoperative pain | This randomized controlled study was carried out in a single institution and was approved by the Medical Ethics Committee of our hospital (KY2021PJ067). It was registered at
Flow chart of the participantsStandard monitoring consisted of a 5-lead electrocardiogram (ECG), pulse oxygen saturation (SpO
Ultrasound image of anterior QLB. The arrow indicates the trajectory of the needle. QL, quadratus lumborum; PM, psoas major; ESM, erector spinae muscles; TP, transverse processAfter that, all patients were subjected to spinal anesthesia in the lateral position. An epidural needle was inserted at L2–L3 or L3–L4 intervertebral space. After reaching the epidural space, a spinal needle was inserted into the subarachnoid space through the epidural needle. A 0.75% ropivacaine (Naropin, AstraZeneca AB Company, Södertälje, Sweden) (1.1–1.8 mL) was administered to achieve a sensory block to the level of T10 dermatome. Then, a catheter was placed in the epidural space. Routine perioperative care was provided to all patients in the operating room. Parecoxib sodium (40 mg) was administered intravenously 15 min before the end of the surgery for postoperative analgesia. Intravenous patient-controlled intravenous analgesia pump with 7 mg/mL tramadol and 0.1 mg/mL tropisetron was administered to all patients. Other routine postoperative pain management consisted of parecoxib sodium (40 mg) twice daily. An intravenous dezocine (5 mg) was used for rescue analgesia if the VAS scores ≥ 4. | PMC10712103 | |
Measurements | postoperative nausea and vomiting [PONV, swelling, toxicity, POCD, painless, pain, PONV, hematoma, urinary retention | DEEP VEIN THROMBOSIS, ADVERSE EFFECTS, SECONDARY, STERILE, HEMATOMA | The primary outcome measure was the frequency (in %) of the occurrence of POCD, defined according to changes in the MoCA scores. The secondary outcome measures were VAS scores at rest and BCS scores 6 h (t1), 12 h (t2), 24 h (t3), and 48 h (t4) after surgery; the plasma levels of HMGB1 and IL-6; the requirement for rescue analgesia; the time to first off-bed activity; and adverse effects after surgery (postoperative nausea and vomiting [PONV], urinary retention, wound swelling, deep vein thrombosis, hematoma, and LA systemic toxicity [LAST]).All patients received the neuropsychological test in a quiet environment by a well-trained anesthesiologist using the MoCA one day preoperatively, seven and 30 days postoperatively. The MoCA [The pain scores on the visual analog scale (VAS) (0, no pain, 10 excruciating pain) at rest, and comfort scores on the Bruggrmann comfort scale (BCS) (0, continuous pain; 1, painless at rest, severe pain while deep breathing or coughing; 2, painless at rest, slight pain while deep breathing or coughing; 3, painless when deep breathing; 4, painless when coughing) was measured 6 h (t1), 12 h (t2), 24 h (t3), and 48 h (t4) after surgery. The requirement for rescue analgesia was also recorded 48 h after surgery.Venous blood samples (5 mL) were collected from all patients 1 h preoperatively (baseline) and 24 h postoperatively (day 1). The samples were put into sterile heparin tubes immediately and centrifuged at 1000×g for 15 min at 4 °C, and the plasma was extracted and stored at − 80 °C for future assays. The plasma concentrations of HMGB1 and IL-6 were tested by a professional biotechnology company (Animalunion Biotechnology Co., Ltd., Shanghai, China) using the ELISA method.In addition, the time to first off-bed activity from the end of surgery, and patients’ self-reported adverse effects (PONV, urinary retention, wound swelling, deep vein thrombosis, hematoma, and LAST) were also recorded 24 h after surgery. All clinical data were collected by staff unaware of the patient’s grouping. | PMC10712103 |
Statistical analyses | POCD | The power analysis for this study was based on a pilot study, which showed a POCD (seven days postoperatively) rate of 5% in the QLB group and 35% in the control group. The pilot study was a randomized controlled study with 20 patients in each group. A sample size calculation using IBM SPSS Sample Power version 3.0 (IBM Corp., Armonk, New York, USA) showed that a sample of 24 participants was required in each group to achieve a statistical power of 0.8 with a significance level alpha of 0.05. Considering the 20% drop-out rate, we increased the number of participants to 30 in each group.SPSS V.24.0 (IBM Corp., Armonk, New York, USA) was used to conduct statistical analyses. Normality was assessed using the Kolmogorov-Smirnov test. Normally distributed data were expressed as the mean and SD, non-normally distributed data were expressed as median and quartiles, and categorical data were expressed as frequency and percentages. Intragroup comparisons were analyzed using the Student’s t-test, while differences in non-normally distributed data were assessed using the Mann–Whitney U test. Categorical data were analyzed using the chi-square ( | PMC10712103 | |
Results | quadratus lumborum block, SD | HYPERTENSION | After screening, a total of 65 patients were recruited for the study. Three patients were excluded for not meeting the inclusion criteria, and two declined to participate. Sixty patients were randomly assigned to the QLB or control groups. Two patients in the QLB group were excluded for failed quadratus lumborum block, one was excluded in the control group for unexpectedly admitting to ICU. None of the three patients were included in the analysis. The final analysis included 28 patients in the QLB group and 29 in the control group. Patient demographic data (age, sex, body mass index, and education) and clinical characteristics (ASA status, comorbidities, type of surgery, and operative time) were comparable between the two groups (Table
Demographics and clinical characteristics of the patients I II10 (35.7%)18 (64.3%)8 (27.6%)21 (72.4%) Hypertension Diabetes13 (46.4%)8 (27.6%)15 (51.7%)7 (24.1%) Osteosynthesis Arthroplasty10 (35.7%)18 (64.4%)13 (44.8%)16 (55.2%)The data are represented as the mean ± SD or number (%)BMI = Body mass index; ASA = American Society of Anesthesiologists | PMC10712103 |
Primary outcome | POCD, Postoperative cognitive dysfunction | POCD occurred in three patients (10.7%) in the QLB group vs. in ten patients (34.5%) in the control group at seven days postoperatively (
Postoperative cognitive dysfunction (POCD) at seven and 30 days postoperatively between the two groups. Data were compared by Fisher’s exact testA repeated-measures ANOVA was applied for comparisons MoCA between the two groups. The intergroup effect, time effect, and interaction effect had statistically significant (
The Montreal Cognitive Assessment (MoCA) scores of the patientsThe data are represented as the mean ± SDMoCA = Montreal Cognitive AssessmentCompared with the control group, | PMC10712103 | |
Secondary outcomes | postoperative pain, postoperative nausea and vomiting, SD, rash | POSTOPERATIVE COMPLICATIONS | As shown in Table
The postoperative pain scores at rest, comfort scores, and rescue analgesia requirements of the patients [score, M(IQR)].The data are represented as the median (interquartile range)VAS = visual analog scale; BCS = Bruggemann comfort scaleCompared with the control group, The plasma concentrations of HMGB1 and IL-6 were comparable between the two groups at baseline (
The plasma concentrations (pg/mL) of HMGB1 and IL-6 at different time pointsBaselineday 1638.3 ± 183.5749.0 ± 185.7667.9 ± 159.4842.1 ± 157.90.5180.0460.1720.540Baselineday 120.8 ± 5.124.8 ± 8.123.4 ± 5.531.9 ± 5.50.070< 0.0010.4901.026The data are represented as the mean ± SDCompared with the control group,
The plasma concentrations of HMGB1 at baseline and day one between the two groups. Data were compared by repeated-measures analysis of variance
The plasma concentrations of IL-6 at baseline and day one between the two groups. Data were compared by repeated-measures analysis of varianceTwo patients in the QLB group were excluded due to failed QLB block, one of which was overweight and quadratus lumborum (QL) muscle, erector spinae, and psoas major couldn’t be identified well, and the other was due to a large rash at the puncture site. The patients in the QLB group had a shorter time to first off-bed activities from the end of surgery than in the control group (
Time to first off-bed and postoperative complications of the patientsThe data are represented as the mean ± SD or number (%)PONV = postoperative nausea and vomiting; LAST = local anesthetic systemic toxicityCompared with group C, | PMC10712103 |
Discussion | toxicity, fracture, POCD, pain, neurocognitive disorders, neurological complications | NEUROLOGICAL COMPLICATION, PATHOGENESIS, INFLAMMATORY RESPONSES, COMPLICATIONS | As common complications in the hip fracture older people population, neurological complications seriously threaten postoperative rehabilitation, decrease mobility, and increase the length of hospital stay [The MoCA is a commonly used cognitive screening method for patients in the early stages of neurocognitive disorders [It has been proved that both preoperative chronic and postoperative acute pain can impair postoperative cognitive function [It has been widely recognized that inflammatory responses play an essential role in the pathogenesis of POCD [Compared to the control group, the patients of the QLB group had a shorter time to first off-bed activity. This indicated that adequate postoperative analgesia provided by QLB could promote early postoperative rehabilitation of patients, consistent with a previous study performed by Kelly et al. [Also, there were certain limitations to this study. First, sensory testing in the QLB group was not performed to avoid unblinding. Second, the sample size was limited, and only MoCA testing was adopted to assess POCD in this study. Therefore, larger sample sizes and multiple tests with different domains of cognition should be performed in further research to gather more evidence. Third, intention-to-treat analysis should be adopted to evaluate the therapeutic effect or exclusion criteria should be modified to ensure that all subjects are eligible for QLB to improve the comparability of experimental results. Last, a dose of 90 mg of ropivacaine was used in this study, and no systemic toxicity was observed. Nevertheless, the ideal LA dosing, volumes, and optimal injection site of QLB in older people still need to be verified. | PMC10712103 |
Conclusions | ANTERIOR | Anterior QLB could accelerate the recovery of early postoperative cognitive function in older people undergoing hip surgery, which may be associated with adequate postoperative analgesia and reduced plasma levels of HMGB1 and IL-6. | PMC10712103 | |
Acknowledgements | The study was supported by the Department of Anesthesiology, Department of orthopaedics, Ningbo Medical Center Lihuili Hospital, Ningbo, China and Department of Anesthesiology, Ningbo beilun people’s hospital. The authors would like to appreciate the efforts of all medical staff and the patients for their participation in this study. | PMC10712103 | ||
Author contribution | Man-hua Zhu and Yu-liu Mei were involved in study concept and design;
Rui-fen Zhou and Ling-zhi Wang collected the data; Xiao-yan Zhang analyzed the data;Man-hua Zhu and Rui-fen Zhou drafted the article; Man-hua Zhu revised the manuscript. | PMC10712103 | ||
Funding | This study was supported by Medical Health Science and Technology Project of Zhejiang Provincial Health Commission (2020KY866). The funding had no role in study design, data collection, analysis, and preparation of the manuscript. | PMC10712103 | ||
Data Availability | The datasets used during the current study are available from the corresponding author on reasonable request. | PMC10712103 | ||
Declarations | PMC10712103 | |||
Ethics approval and consent to participate | This study was approved by the Medical Ethics Committee of Ningbo Medical Center Lihuili Hospital, China (KY2021PJ067), and the protocol was registered at the Chinese Clinical Trial Registry (ChiCTR2000040724) (prospectively registered). The initial registration date was 08/12/2020. All procedures performed in this study involving human participants were in accordance with the Ethical Standards of the Institutional Ethics Committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All patients signed written informed consent before surgery. | PMC10712103 |
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