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IRCT20230130057273N3 IRCT 2025-12-17 Tehran University of Medical Sciences Comparative study of transversus abdominis nerve block with rectus sheath nerve block in pain control after laparoscopic cholecystectomy in patients of Imam Khomeini Hospital Complex, 2026 Comparative study of transversus abdominis nerve block with rectus sheath nerve block in pain control after laparoscopic cholecystectomy 2026-01-21 anticipated 60 Recruiting https://irct.ir/trial/87909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this randomized clinical trial, eligible patients will be allocated after confirmation of the inclusion/exclusion criteria and obtaining written informed consent. Participants will be assigned using simple randomization with a 1:1 allocation ratio to one of the following two groups: the TAP block group (transversus abdominis plane block) and the rectus sheath block group. 1) Randomization method Type of randomization: Simple randomization (without blocking and without stratification). For each participant, an independent random assignment will be generated and allocated to one of two groups (A/B). Quasi-random methods (e.g., alternating assignment, date of birth, medical record number, day of visit, etc.) will not be used. 2) Unit of randomization Unit: Individual randomization; each patient constitutes an independent unit for allocation. Cluster or multilevel randomization will not be performed in this study. 3) Stratification Stratified randomization will not be used. All eligible participants will enter the randomization process without stratification. 4) Randomization tools Random sequence generation tool: Computer-generated random numbers using SPSS. Allocation implementation at the bedside: Sequentially numbered, opaque, sealed envelopes (SNOSE). 5) Generation of the random sequence The allocation sequence will be generated by an individual independent of the clinical implementation team. A list of assignments with a length equal to the required sample size will be created, and for each entry, allocation to A or B will be generated with equal probability (0.5/0.5). The final output will be a serial list in which each sequential number corresponds to a specific allocation (A/B). 6) Allocation concealment To minimize selection bias, allocation concealment will be ensured using the SNOSE method. Envelopes will be opaque, light-impermeable, sealed, and sequentially numbered. Each envelope will contain a card indicating the group code (A = TAP, B = Rectus Sheath). Envelopes will be prepared by an independent person and stored securely. The envelope will be opened only after final confirmation of patient eligibility and documentation of written informed consent, Blinding description: To minimize bias, participants, postoperative care staff, data collectors, and outcome assessors will be blinded to group allocation. The blocks will be performed after induction of general anesthesia, and identical dressings will be applied over the injection sites. Group allocation will be implemented using sequentially numbered, opaque, sealed envelopes (SNOSE) and will be disclosed only to the anesthesiologist performing the block; in documents accessible to outcome assessors, allocation will be recorded only as code A/B. The postoperative pain management protocol will be identical and pre-standardized in both groups. Statistical analyses will be conducted using coded groups, and unblinding will take place only after database lock. 3 Acute pain occurring in the early postoperative period after elective laparoscopic cholecystectomy, requiring postoperative analgesia.. Intervention 1: Intervention group: After induction of general anesthesia and before surgical incision, participants receive an ultrasound guided transversus abdominis plane block. A total of 20 millilitres of bupivacaine 0.25 percent is injected into the appropriate plane. All other anesthesia components and the postoperative pain management protocol are standardized according to the study protocol. Intervention 2: Intervention group: After induction of general anesthesia and before surgical incision, participants receive an ultrasound guided rectus sheath block. A total of 20 millilitres of bupivacaine 0.25 percent is injected into the rectus sheath plane. All other anesthesia components and the postoperative pain management protocol are standardized according to the study protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Babak Eslami
Baqerkhan Ave, Chamran Highway
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 beslami@sina.tums.ac.ir Tehran University of Medical Sciences scientific Babak Eslami
Baqerkhan Ave, Chamran Highway
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 beslami@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) ASA class I & II Informed consent to participate in the project BMI between 18 and 35 20 years 60 years Both Allergy to anesthetic drugs used in the plan failure of the chosen method Patient's unwillingness to participate in the plan Localized sepsis at the site of the block Alcohol or drug abuse History of any coagulation disorder Surgery time more than 3 hours Surgeries in which the patient experiences surgical complications during the operation for any reason Any mental or psychological disorder History of serious painful illness R52 Pain, unspecified Treatment - Drugs Treatment - Drugs Intervention group: After induction of general anesthesia and before surgical incision, participants receive an ultrasound guided transversus abdominis plane block. A total of 20 millilitres of bupivacaine 0.25 percent is injected into the appropriate plane. All other anesthesia components and the postoperative pain management protocol are standardized according to the study protocol. Intervention group: After induction of general anesthesia and before surgical incision, participants receive an ultrasound guided rectus sheath block. A total of 20 millilitres of bupivacaine 0.25 percent is injected into the rectus sheath plane. All other anesthesia components and the postoperative pain management protocol are standardized according to the study protocol. Postoperative pain intensity at rest. Timepoint: 2, 6, 12, and 24 hours after surgery. Method of measurement: Visual analogue scale, a 10 centimetre line anchored by no pain and worst imaginable pain. Cumulative intravenous morphine dose administered during the first 24 hours after surgery. Timepoint: From the end of surgery to 24 hours after surgery. Method of measurement: Total intravenous morphine dose extracted from the medication administration record and patient chart. Total intravenous fentanyl dose administered intraoperatively. Timepoint: At the end of surgery, as the cumulative dose from induction of anesthesia to the end of surgery. Method of measurement: Total intravenous fentanyl dose extracted from the anesthesia record and intraoperative medication chart. Need for intravenous ketorolac administration in the post anesthesia care unit. Timepoint: During the post anesthesia care unit stay, from admission to discharge. Method of measurement: Documentation of intravenous ketorolac administration in the post anesthesia care unit medication administration record. Incidence of block related complications. Timepoint: During block performance and up to 24 hours after surgery. Method of measurement: Clinical assessment and documentation of adverse events including injection site hematoma or bleeding, signs of local infection, signs of local anesthetic systemic toxicity, and any other reported adverse events. Tehran University of Medical Sciences Approved 2025-09-30 Ethics Committee of Tehran University of Medical Sciences Keshavarz Blvd., Central Building of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)