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Study protocol | brachial plexus block | STERILE, PERIOSTEUM | The surgical procedure was as follows: after the patient was brought to the anaesthesia preparation room, the venous channel was opened, and electrocardiogram, oxygen saturation values and blood pressure were monitored. All operations were performed under ultrasound guidance. Patients were grouped by anaesthesiologist:... | PMC10371927 |
Outcomes measurement | postoperative pain | PARTIAL PARALYSIS, SECONDARY, DIAPHRAGM | The primary observation outcome was the time of first use of analgesics. Whenever postoperative pain scores were above 4, 50 mg parecoxib sodium was administered intravenously.As a secondary outcome, the effect of the block was measured at 30 min in three areas: sternoclavicular joint, midclavicular and acromioclavicul... | PMC10371927 |
Statistical analysis | The primary outcome of this study was the time of the first postoperative analgesia. After reviewing the relevant literature [We used SPSS version 26.0 for the data analysis. Normally distributed data are expressed as the mean ± standard deviation, with two independent sample t tests. Count data are expressed as the ra... | PMC10371927 | ||
Results | PMC10371927 | |||
The VAS pain scores | pain | The VAS pain scores at 6 and 12 h were not different between the two groups; however, the VAS pain score at 24 h in group I was lower than that in group II (P < 0.01) (Table | PMC10371927 | |
Hemidiaphragmatic excursion during the sign test | paresis, hemidiaphragmatic paresis | PARESIS | Diaphragmatic movement was evaluated by real-time M-mode ultrasonography of the ipsilateral hemidiaphragm. Patients were examined in an upright seated position. The range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) was recorded before and 30 min after the block. The ba... | PMC10371927 |
Adverse reaction | haemothorax, nerve injury, Horner syndrome | HAEMOTHORAX, HORNER SYNDROME, LOCAL ANAESTHETIC SYSTEMIC TOXICITY, PNEUMOTHORAX | There were no reports of local anaesthetic systemic toxicity, nerve injury, pneumothorax, haemothorax, high epidural block, or total spinal anaesthesia. However, 3 patients in group II developed Horner syndrome (Table | PMC10371927 |
Discussion | critically ill, hemidiaphragmatic, Pain, fracture, pain, fractures | ADVERSE REACTIONS, CRITICALLY ILL | In 2017, Valdés first proposed the regional anaesthesia technique CPB at the 36th European Society of Regional Anesthesia & Pain Therapy (ESRA) Symposium. Under the guidance of ultrasound, 10–15 mL of local anaesthesia was injected between the clavipectoral fascia and the superior aspect of the clavicle. Several case s... | PMC10371927 |
Acknowledgements | Assistance with the study: We would like to thank Dr. Bing Cai, Senior Consultant Anaesthesiologist, for his assistance with the study and Dr. Peng Su for statistical assistance. | PMC10371927 | ||
Author contributions | All authors contributed to the study conception, design, material preparation, data collection and analysis. The first draft of the manuscript was written by GX. All authors read and approved the final manuscript and agreed to be accountable for all aspects of the work study. | PMC10371927 | ||
Funding | We received research support from The Sichuan Academy of Medical Sciences Sichuan Provincial People’s Hospital 2021 Clinical Application New Technology Project (Grant No: 202168), Medico-Engineering Cooperation Funds from University of Electronic Science and Technology of China (ZYGX2021YGLH221) and Sichuan Provincial ... | PMC10371927 | ||
Data Availability | The data that support the findings of this study can be obtained from the corresponding author upon reasonable request. | PMC10371927 | ||
Declarations | PMC10371927 | |||
Conflict of interest | The authors have no relevant financial or nonfinancial interests to disclose. | PMC10371927 | ||
Ethical approval | This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Institutional Review Board of Sichuan Provincial People’s Hospital on 27 Nov 2020. | PMC10371927 | ||
Consent to participate | Written informed consent was obtained from all individual participants included in the study. | PMC10371927 | ||
Consent to publish | Not applicable. | PMC10371927 | ||
References | PMC10371927 | |||
Methods | Pain, knee osteoarthritis, KOA | KNEE OSTEOARTHRITIS | Edited by: Yun Shen, Pennington Biomedical Research Center, United StatesReviewed by: Xin Zhang, Tongji University, ChinaYang Sun, Fudan University, ChinaTo compare the reliability and effectiveness of blood blow restriction resistance training (BFR) versus traditional weight-bearing training (WB) in knee osteoarthriti... | PMC10753484 |
Results | pain | 112 patients (57 in the WB group, 55 in the BFR group) completed the training programs and assessments. No significant intergroup demographic differences were noted. ROM and scaled 10RM significantly increased at the 4- and 12-week assessments and differed significantly between groups. The pain, ability of daily living... | PMC10753484 | |
Conclusion | KOA, pain | BFR training enhanced muscle strength, reduced pain, and improved daily living and sports activities in patients with KOA, compared to WB training alone. BFR should be recommended for rehabilitation in KOA individuals with MASLD. | PMC10753484 | |
Clinical trial registration number | ChiCTR2100042872. | PMC10753484 | ||
Introduction | MASLD, Knee osteoarthritis, pain, KOA | BLOOD, DISEASE, KNEE OSTEOARTHRITIS | Knee osteoarthritis (KOA), especially those cases involving the medial compartment of the tibiofemoral joint, has become a major public health problem worldwide (Exercise therapy can reduce the pain symptoms of KOA at different disease stages (Blood flow restriction (BFR) training is a new strength training method that... | PMC10753484 |
Methods | PMC10753484 | |||
Participants | knee fracture, knee pain, trauma | DISEASES, DEGENERATION, AUTOIMMUNE | This multicenter randomized controlled trial was conducted from January 2021 to June 2022 in two trauma centers (Shanghai Jiao Tong University affiliated Sixth People’s Hospital and The People’s Hospital of Mengla County). A total of 120 eligible outpatients were recruited for this two-arm single-assessor blinded rando... | PMC10753484 |
Sample size | Osteoarthritis, Knee Injury, pain | OSTEOARTHRITIS | The primary outcome measure of pain (Knee Injury and Osteoarthritis Outcome Score [KOOS] pain) was used to calculate the required sample size using G*power version 3.1 (Heinrich-Heine-Universität Düsseldorf Universitätsstr, Germany) ( | PMC10753484 |
Experimental design | trauma | Two trauma centers joined this two-arm, single-assessor blinded randomized controlled trial. All recruited patients were block randomized to the WB (n=60) or BFR (n=60) group by an independent research team member. The blinding procedure was performed using opaque envelopes (n=60 for each group). Each participant was a... | PMC10753484 | |
Experimental procedure | diabetes | DIABETES | The patients’ demographic data, including age, sex, BMI, smoking, diabetes, and Kellgren and Lawrence system grade, were recorded, as were their baseline data, including ROM, muscle strength (scaled maximal isotonic strength [10RM]), KOOS subscales, and 30-s chair sit-to-stand test results. All participants were then i... | PMC10753484 |
WB training | knee extension | Each WB training intervention session included three parts: stretching exercise, ROM exercise, and strength exercise. The stretching exercises included triceps stretching in the standing position, hamstring stretching in the supine position, and quadriceps stretching in the prone position. The ROM exercises included kn... | PMC10753484 | |
BFR training | arterial occlusion | ARTERIAL OCCLUSION | An automatically personalized tourniquet (PT) system (Delfi Medical, Vancouver, BC, Canada) was used in the BFR group. The system, set to automatically calculate occlusion pressure of the lower limb (LOP) defined as the minimum pressure required for full arterial occlusion ( | PMC10753484 |
Pain | pain | The pain was evaluated using the pain subscale of the KOOS (9-question, with a score of 0 indicating extreme pain to 36 indicating no pain). | PMC10753484 | |
Range of motion | Knee flexion was measured using a goniometer with each patient positioned supine and moving the heel as close as possible to the buttocks. Knee extension was measured with the patient maximally extending the knee joint and recorded as the difference from 0° of extension. The ROM of the knee was calculated as maximum fl... | PMC10753484 | ||
Muscle strength | Scaled 10RM strength was assessed using a MED leg press (Technogym, Bracknell, UK) following a warm-up of 10 min light cycling. Beginning at 80% estimated 10RM the maximum load that could be lifted ten times through complete, the full ROM performed using the correct form was recorded as the concentric 10RM. All 10RM va... | PMC10753484 | ||
Physical function | pain | The KOOS is a self-reported tool used to assess patients’ opinions of their knee function and associated problems. The KOOS has five subscales: pain, symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Each subscale includes questions with standardized answer options ... | PMC10753484 | |
Data storage and analysis | pain | DISEASE | All patients’ data were coded and stored on the electronic data capture system for a specific disease. The system was operated within the hospital’s local servers. All statistical analyses were performed using SPSS Statistics version 24.0 (IBM Corp, Chicago, IL, USA). Data are presented as mean ± SD with 95% confidence... | PMC10753484 |
Results | PMC10753484 | |||
Participants and rehabilitation program | Eight participants (5 in the BFR group, 3 in the WB group) failed to complete the study due to unplanned surgery and injury (n=5) and unrelated reasons (n=3). The remaining 112 participants (93%) completed the study and the follow-up survey. There were no significant intergroup differences in baseline demographic data ... | PMC10753484 | ||
Pain | pain | Statistically significant improvement in KOOS pain scores were detected at the 4- and 12-week follow-up assessments, with significant intergroup differences at 12 weeks (Results of pain, ROM, and physical function at baseline, week 4 and 12.Data were presented as mean ± SD. Kg/kg as a unit presented the ratio of the we... | PMC10753484 | |
Range of motion | A statistically significant increase in knee ROM was noted at 4 and 12 weeks, with a significant intergroup difference ( | PMC10753484 | ||
Scaled 10RM muscle strength | Scaled 10RM strength increased significantly from baseline to 12-week follow-up with significant intergroup differences ( | PMC10753484 | ||
Physical function | Statistically significant difference was noted for all KOOS subscale scores. The scores of subscales of symptoms, ability in daily living, function in sports and recreation, and knee-related quality of life showed significant intergroup differences at the 12-week follow-up (The mean 30s-CST increased significantly from... | PMC10753484 | ||
Discussion | KOA, pain | OBESE | This study was the first to assess the effects of a 12-week BFR training program on pain, muscle strength, and physical function among individuals with KOA complicated with MASLD. This study targeted middle-aged and elderly obese patients with a higher incidence of knee OA than other populations and aimed to evaluate t... | PMC10753484 |
Pain | KOA, OA, pain | OBESE | Different studies have evaluated the effects of training programs on pain, symptoms, physical function, and quality of life among patients with OA (The subjects of this study were obese individuals with KOA who experience greater joint stress involving a cycle of pain and loss of strength and knee function due to damag... | PMC10753484 |
Muscle strength | effusion, pain | EFFUSION | Muscle strength and volume increases have been reported after all exercise protocols regardless of duration (4–12 weeks). Recent studies reported that 8–13% of knee extensor muscle strength could be recovered with the aid of BFR (Arthrogenic inhibition is associated with joint cartilage impairments, effusion, and pain ... | PMC10753484 |
Physical function | hypoalgesia, knee pain | The significant and clinically important improvements in all patient’s self-reported function measures and 30s-CST performance results observed in both groups are in line with those of recent studies of knee OA patients (Recent research also suggested that BFR may have a hypoalgesia effect, as knee pain was significant... | PMC10753484 | |
Implications for clinical knee OA rehabilitation | Pain, pain | The application of BFR passively or in combination with aerobic exercise during early anterior cruciate ligament rehabilitation was discussed previously (Pain extent is a major factor affecting knee OA rehabilitation results, as the pain has a detrimental effect on motor control and muscle function that results in modi... | PMC10753484 | |
Study strengths and limitations | KOA | STILL | During knee OA rehabilitation, applying progressively heavier loads is important to preventing muscular adaptations to the exercise (Muscle morphology is another parameter used to evaluate functional outcomes of training. Still, it was not used in our study due to the 4.2–13.0 MHz wide-band linear array scanning transd... | PMC10753484 |
Conclusion | KOA, pain | The present study demonstrated that BFR training could improve knee strength better than WB training alone, affording a greater reduction in pain and leading to greater overall improvements in functional outcomes of daily living and sport and leisure for KOA patients with MASLD. | PMC10753484 | |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. Requests to access these datasets should be directed to | PMC10753484 | ||
Ethics statement | The studies involving humans were approved by the Research Ethics Committee of Shanghai Jiao Tong University affiliated Sixth People’s Hospital. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in ... | PMC10753484 | ||
Author contributions | Conception and design: CH, CL. Acquisition, analysis, or interpretation of data: BZ, YW, FY, JZ, WZ, SL. Drafting: CH, SL. Revising: CL. All authors contributed to the article and approved the submitted version. | PMC10753484 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10753484 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10753484 | ||
References | PMC10753484 | |||
Abstract | toxicities, DLTs, multiple mieloma, MM | ONCOLOGY, RELAPSED/REFRACTORY MULTIPLE MYELOMA, REFRACTORY MULTIPLE MYELOMA | Previous studies showed antitumor activity for plitidepsin plus dexamethasone (DXM) in relapsed/refractory multiple myeloma (r/r MM), and in vitro synergism with bortezomib (BTZ) or DXM against MM cells. This phase I trial evaluated plitidepsin (3‐h intravenous infusion Day 1 and 15), BTZ (subcutaneous bolus Day 1, 4, ... | PMC9972151 |
INTRODUCTION | Multiple myeloma, malignancy, hematological malignant diseases, MM | MULTIPLE MYELOMA | Multiple myeloma (MM) is a B‐cell malignancy accounting for 10% of hematological malignant diseases worldwide, with about 120,000 new cases every yearThe feasibility of re‐treating MM patients with single‐agent bortezomib (BTZ) was first confirmed in the phase III VISTA trial,Plitidepsin is a cyclic depsipeptide origin... | PMC9972151 |
METHODS | This study was conducted at six centers in Spain and one in France according with the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulations for clinical trials. The study protocol was approved by the Independent Local Ethics Committee of each center. Signed written informed consent was obtai... | PMC9972151 | ||
Patient population | toxicities, alopecia, MM | ONCOLOGY, ALOPECIA | Inclusion criteria were age ≥ 18 years; r/r MM diagnosed according to Durie‐Salmon criteria; ≥1 previous treatment lines; recovery from previous toxicities to grade ≤ 1 (excluding alopecia); Eastern Cooperative Oncology Group performance status score ≤ 2; normal left ventricular ejection fraction (LVEF); platelet count... | PMC9972151 |
Study treatment | DISEASE | Treatment consisted of escalating doses of plitidepsin 3‐h intravenous (i.v.) infusion Day 1 and 15, and BTZ subcutaneous bolus injection Day 1, 4, 8, and 11, with fixed DXM dose 40.0 mg orally Day 1, 8, 15, and 22, all every 4 weeks (q4wk), for a maximum of 8 cycles. If response or disease stabilization was observed, ... | PMC9972151 | |
Dose escalation | Dose escalation followed a standard 3 + 3 design. The starting plitidepsin dose (4.0 mg/m | PMC9972151 | ||
Study assessments | Cancer | ADVERSE EVENT, ADVERSE EVENT, MYELOMA, CANCER | Hematology and biochemistry tests were done at baseline, before each plitidepsin or BTZ administration during Cycle 1, and before each plitidepsin administration during subsequent cycles.Adverse events (AEs) and laboratory abnormalities were graded using the National Cancer Institute Common Terminology Criteria for Adv... | PMC9972151 |
Pharmacokinetic analyses | Sixteen samples were collected from each patient to quantify plitidepsin whole blood and BTZ plasma concentrations at baseline and at different times 1 week after the first infusion. In patients treated at the RD, 15 additional samples were taken 1 week after the second plitidepsin infusion. | PMC9972151 | ||
Statistical analyses | Continuous variables were presented with summary statistics and categorical variables in frequency tables. Time‐to‐event variables were calculated using Kaplan–Meier approach. Binomial exact distribution was used to calculate 95% confidence intervals (95%CIs) for categorical variables. Individual PK parameters were tab... | PMC9972151 | ||
RESULTS | PMC9972151 | |||
Patient characteristics and treatment | MM, Relapsed, stage IA.Includes stage IIA, PD, MR | MULTIPLE MYELOMA, MINOR, DISEASE, ONCOLOGY, MYELOMA | A total of 39 patients were enrolled between June 2014 and August 2018. Of these, 36 patients were treated at three dose levels: eight at DL1 (plitidepsin 4.0 mg/mOf the 39 enrolled patients at all dose levels, with median age 66 years (range, 51–80 years), 19 (49%) had previously received hematopoietic stem cell trans... | PMC9972151 |
Dose‐limiting toxicities and recommended dose | nausea, pneumonia, DLTs, diarrhea, toxicities, nausea and vomiting, vomiting, PD | PNEUMONIA | Twelve of the 22 patients treated at the escalation stage were evaluable for dose‐limiting toxicities (DLTs).The other10 patients were non‐evaluable for RD. Six of these patients did not receive a complete Cycle 1 (two patients discontinued before ending Cycle 1 due to pneumonia unrelated to treatment, one due to early... | PMC9972151 |
Toxicity profile | discontinuations, nausea, Thrombocytopenia, hematological abnormalities, diarrhea, fatigue, febrile neutropenia, neutropenia, toxicity, paresthesia, vomiting, anemia, hematological abnormality, abnormal blood cell counts (grade ≥ 2), Neutropenia, peripheral neuropathy, Cancer | ADVERSE EVENT, THROMBOCYTOPENIA, NEUTROPENIA, FEBRILE NEUTROPENIA, ADVERSE EVENTS, THROMBOCYTOPENIA, PARESTHESIA, ANEMIA, NEUTROPENIA, PERIPHERAL NEUROPATHY, CANCER | The most common treatment‐related AEs found among the 36 patients treated at all dose levels were nausea (36% of patients), fatigue (28%), diarrhea (25%), and peripheral neuropathy and vomiting (19% each). Most of these AEs were grade 1/2. Grade ≥ 3 treatment‐related AEs at all dose levels comprised fatigue (Among the ... | PMC9972151 |
Efficacy | Twenty‐eight, PD | DISEASE, MINOR, MYELOMA, RELAPSED/REFRACTORY MULTIPLE MYELOMA | Twenty‐eight patients treated at all dose levels (18 at the RD cohort) were evaluable for efficacy as per IMWG criteria. Eight patients were not evaluable because they did not receive at least one complete cycle. Overall, 10 patients showed PR or better, including two sCRs, one CR, three VGPRs, and four PRs (ORR = 35.7... | PMC9972151 |
Pharmacokinetics | All patients were sampled for PK analysis, but only 17 and 18 of them were suitable for NCA of plitidepsin and BTZ, respectively. Mean total body clearance (CL) and volume of distribution (Non‐compartmental pharmacokinetic parameters
Abbreviations: AUC, area under the concentration–time curve from time zero to infinity... | PMC9972151 | ||
DISCUSSION | myalgia, MM, diarrhea, fatigue, thrombocytopenia, hematological toxicity, muscular toxicity, vomiting, anemia, hematological abnormality, muscular weakness, nausea, | DISEASE, THROMBOCYTOPENIA, RELAPSED/REFRACTORY MULTIPLE MYELOMA, ANEMIA, EVENTS | The RD for phase II studies for this triple combination was plitidepsin 5.0 mg/mThe most common hematological abnormality (all grades) was anemia, which occurred in all patients (grade ≥ 3 in 33% at the RD). Most cases were grade 1/2, and at the RD the majority of patients with grade ≥ 3 anemia while on treatment alrea... | PMC9972151 |
AUTHOR CONTRIBUTIONS | ALBERT | María Victoria Mateos: Conceptualization, Investigation, Resources, Writing—original draft, Writing—review & editing. Felipe Prosper: Investigation, Resources, Writing—review & editing. Jesús Martin Sánchez: Investigation, Resources, Writing—review & editing. Enrique M. Ocio: Methodology, Investigation, Resources, Writ... | PMC9972151 | |
FUNDING INFORMATION | The study was funded by Pharma Mar, S.A. | PMC9972151 | ||
CONFLICT OF INTEREST | ONCOLOGY | María Victoria Mateos has received honoraria for lectures and participation in advisory boards from Janssen, Celgene, Takeda, Amgen, GSK, AbbVie, Pharma Mar, Pfizer, Regeneron, Roche, Sanofi, Oncopeptides, and Seagen. Enrique M. Ocio has received honoraria or consultation fees from Janssen, BMS/Celgene, Sanofi, GSK, On... | PMC9972151 | |
Supporting information | APPENDIX |
Appendix S1
Click here for additional data file. | PMC9972151 | |
ACKNOWLEDGMENTS | The authors thank the patients, their families, and investigators teams for their participation in this phase I clinical trial. | PMC9972151 | ||
DATA AVAILABILITY STATEMENT | Individual participant data are not publicly available since this requirement was not anticipated in the study protocol considering that this trial started patient enrolment in 2014. Clinical trial summary results were placed in the European Clinical Trials Database (EudraCT; study 2013–003835‐31) and Clinical | PMC9972151 | ||
REFERENCES | PMC9972151 | |||
2. Materials and Methods | PMC10222609 | |||
2.1. Design | neurological diseases, infectious | PULMONARY EMBOLISM, NEUROLOGICAL DISEASE, COAGULATION DISORDERS, DEEP VEIN THROMBOSIS, CORONARY DISEASES | We conducted a randomized controlled trial of patients following a primary total knee replacement between October 2020 and August 2021 in our center. We excluded from our study patients with revisions and cases requiring a greater constraint than a posterior stabilized TKA (constrained or hinged knee). We also excluded... | PMC10222609 |
2.2. Surgical Technique | knee arthroplasty, Arthritis, femoral nerve block, TKA | ARTHRITIS, COMPLICATIONS, DEEP VEIN THROMBOSIS | All TKA procedures were performed by a single, highly experienced orthopedic surgeon in our institution, who specializes in total knee arthroplasty, according to a standard protocol. The implant of choice was the Zimmer Biomet NexGen implant system. Preoperatively, 1 g of tranexamic acid was administered in all cases, ... | PMC10222609 |
2.3. Outcome Measures | pain | OSTEOARTHRITIS | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was the primary outcome measure of this paper; this is a questionnaire consisting of 3 subsections (pain, stiffness and function) and comprises 24 items [The Visual Analogue Scale is a measure of pain to determine the patient’s perspective of pa... | PMC10222609 |
2.4. Statistical Analysis | Continuous variables were normally distributed and were presented as means and standard deviations. A statistical analysis was performed by using an independent t-test. Categorical data were analyzed using the Chi-square test. All of the statistical analysis was performed by an independent statistician using SPSS versi... | PMC10222609 | ||
3. Results | blood loss, ±, pain | DEEP VEIN THROMBOSIS, BLOOD LOSS, COMPLICATION, ARTHROFIBROSIS, COMPLICATIONS | We included 96 patients in the T group and 94 in the NT group, respectively, who remained part of this study until the last follow-up. All 10 cases that dropped out have been excluded. Regarding patient age and gender, we did not identify any significant differences. (Regarding blood loss, the NT group demonstrated sig... | PMC10222609 |
4. Discussion | blood loss, TKAs, pain | BLOOD LOSS, BLIND, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | Tourniquet usage for TKAs has been under debate for a long time. However, the evidence regarding this topic from our country is lacking. Thus, we decided to develop this detailed study. The evidence from the literature is conflicting regarding blood loss, function and complications. Therefore, we opted for a prospectiv... | PMC10222609 |
Author Contributions | S.D. planned the clinical study, and contributed to the conception and design of this study, as well as the acquisition and data analysis. C.D. contributed to the conception and design of this study. M.E.G. contributed to the analysis and data interpretation. M.P. planned the clinical study, and contributed to the conc... | PMC10222609 | ||
Institutional Review Board Statement | All procedures performed in this paper were in accordance with the 1964 Helsinki Declaration and its later amendments, or comparable ethical standards, and according to the national ethical standards. This study received approval from the “Foisor” Orthopaedics Clinical Hospital Ethics Committee of Bucharest, Romania, a... | PMC10222609 | ||
Informed Consent Statement | Informed consent was obtained from all participants. The procedures were conducted in accordance with national ethical standards and the 1964 Helsinki Declaration. We declare that this paper does not contain any individual personal details. | PMC10222609 | ||
Data Availability Statement | All data generated or analyzed are included in this published article. | PMC10222609 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10222609 | ||
Abbreviations | List of abbreviations.
| PMC10222609 | ||
References | Baseline characteristics.Intraoperative and postoperative parameters. * statistically significant.Postoperative results during follow-ups. * statistically significant. | PMC10222609 | ||
Background and aim | coronary artery bypass, acute pain, pain | COLD | Chest tube removal (CTR) can cause severe acute pain which is usually described by patients as a painful experience. This study compared the effects of cold compress, transcutaneous electrical nerve stimulation (TENS), and combined cold compress-TENS on CTR-associated pain among patients with coronary artery bypass gra... | PMC10214554 |
Methods | pain | COLD | This randomized controlled trial was conducted in 2018–2019 using a double-blind four-group design. Participants were 120 patients with CABG selected from Shafa hospital, Kerman, Iran, and randomly allocated to a cold compress, a TENS, a combined cold compress-TENS, and a placebo group (compress with room temperature) ... | PMC10214554 |
Results | pain | COLD | The data of 29 participants in the placebo group, 26 in the TENS group, 30 in the cold compress group, and 26 in the combined cold compress-TENS group was gathered. Baseline demographic and clinical characteristics and pain intensity scores of participants had no statistically significant differences among all four gro... | PMC10214554 |
Conclusion | pain | COLD | Combined cold compress-TENS is more effective than separate cold compress and TENS in reducing CTR-associated pain among patients with CABG. Therefore, non-pharmacological methods such as combined cold compress-TENS are recommended for managing CTR-associated pain. | PMC10214554 |
Keywords | PMC10214554 | |||
Introduction | nausea, dyspnea, Cardiovascular disease, pain, postoperative death | RESPIRATORY INFECTIONS, CARDIOVASCULAR DISEASE, CARDIOVASCULAR DISEASE, GASTROINTESTINAL BLEEDING, COLD, RESPIRATORY COMPLICATIONS, COLD, COMPLICATIONS | Cardiovascular disease is one of the major health challenges [Cardiac surgery is a common treatment for cardiovascular disease [Ineffective pain management among patients with cardiac surgery can increase the risk of postoperative respiratory complications such as reduced respiratory muscle strength, reduced lung volum... | PMC10214554 |
Methods | cardiac dysrhythmia, Raynaud’s disease, pain, sensory disorders, audiovisual impairments, vasovagal | CARDIAC DYSRHYTHMIA, DISORDERS, SENSORY DISORDERS, BLIND, COLD | This randomized controlled trial was conducted in 2018–2019 using a double-blind four-group design. Participants were 120 hospitalized adult patients with CABG recruited from the cardiac surgery intensive care unit of Shafa hospital, Kerman, Iran. They were selected based on the following selection criteria: an age of ... | PMC10214554 |
Instruments | chest pain, pain | CHRONIC DISEASE | Data collection instruments were a demographic questionnaire, a clinical data sheet, and a visual analogue scale. The items of the demographic questionnaire were related to age, gender, educational level, body mass index, occupation, pain tolerance, history of chronic disease, history of cigarette smoking, and family h... | PMC10214554 |
Intervention | STERILE, COLD | Study intervention for all participants in all groups was implemented 15 min before CTR. In the cold compress group, the skin surrounding the chest tube insertion site was cleansed using alcohol and then, a cold compress with a temperature of – 5 °C was applied to the site for 15 min so that it covered an area of 10-cm... | PMC10214554 |
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