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IRCT20260704070072N1 IRCT 2026-08-15 Shahid Beheshti University of Medical Sciences Comparison of Two Abdominal Nerve Blocks and Standard Pain Treatment for Pain Relief After Laparoscopic Gallbladder Surgery Analgesic Efficacy of the TARAA Block (Transversus Abdominis–Rectus Abdominis Aponeurosis Block) Versus TAP Block and Standard Care in Patients Undergoing Laparoscopic Cholecystectomy: A Three-Arm Randomized Controlled Trial 2026-09-20 anticipated 60 Pending https://irct.ir/trial/92473 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomized individually in a 1:1:1 ratio to the TARAA block, TAP block, or standard care group. Balanced permuted block randomization with a block size of 6 will be used. The random allocation sequence will be generated by an independent person who is not involved in participant enrollment or implementation of the interventions. No stratification will be used. Group assignments will be placed in sequentially numbered, sealed envelopes. The envelopes will be opened only after participant enrollment and confirmation of eligibility criteria. Therefore, allocation concealment will be maintained until group assignment, Blinding description: The anesthesiologist performing the regional block cannot be blinded to group allocation because the TARAA and TAP techniques are different and the standard-care group does not receive a nerve block. Therefore, the investigator responsible for performing the intervention is not blinded. Participants are not considered blinded because no sham block is performed in the standard-care group. The outcome assessor and data collector will be blinded to group allocation. Postoperative outcomes, including pain scores, morphine consumption, postoperative nausea and vomiting, patient satisfaction, and block-related adverse events, will be recorded by a research nurse who is unaware of the allocated study group. The statistical data analyser will also remain blinded to group allocation. Study groups will be coded before statistical analysis so that the analyser cannot identify the intervention corresponding to each code. No Data and Safety Monitoring Board is planned for this trial. N/A Acute postoperative pain after laparoscopic cholecystectomy. Intervention group: Before induction of general anesthesia, bilateral ultrasound guided Transversus Abdominis Rectus Abdominis Aponeurosis block will be performed by an anesthesiologist experienced in regional anesthesia. A linear ultrasound probe will be placed in the supraumbilical region, lateral to the midline. After identification of the rectus abdominis and transversus abdominis aponeurotic layers, the block needle will be advanced using an in plane technique. Twenty milliliters of 0.2% ropivacaine will be injected on each side in the targeted aponeurotic plane. Patients will also receive the standard systemic postoperative analgesic protocol used in all study groups.. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data and data dictionary. The dataset will include deidentified participant-level demographic, clinical, intervention, and outcome data collected during the trial, including morphine consumption, postoperative pain scores, time to first rescue analgesia, postoperative nausea and vomiting, patient satisfaction, and block-related adverse events. Direct personal identifiers will not be shared. When: After data collection completion To whom: Other researchers Conditions: belonging to academic institution Where to obtain: researcher's personal email: dr.alirezashakeri@gmail.com How to obtain: requesting by email Comments:
public َAlireza Shakeri
Emam Hosein Hospital - Shahid Madani St - Tehran - Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences scientific Alireza Shakeri
Emam Hosein Hospital - Shahid Madani St - Tehran - Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients scheduled for elective laparoscopic cholecystectomy Age between 18 and 65 years American Society of Anesthesiologists (ASA) physical status I or II Proviیهدل of written informed consent to participate in the study. 18 years 65 years Both History of allergy to amide local anesthetics. Coagulation disorder defined as platelet count below 80,000/µL or INR above 1.5. Chronic opioid use for more than 3 months. Local infection at the planned block injection site. Pregnancy K80.2 Calculus of gallbladder without cholecystitis Treatment - Other Intervention group: Before induction of general anesthesia, bilateral ultrasound guided Transversus Abdominis Rectus Abdominis Aponeurosis block will be performed by an anesthesiologist experienced in regional anesthesia. A linear ultrasound probe will be placed in the supraumbilical region, lateral to the midline. After identification of the rectus abdominis and transversus abdominis aponeurotic layers, the block needle will be advanced using an in plane technique. Twenty milliliters of 0.2% ropivacaine will be injected on each side in the targeted aponeurotic plane. Patients will also receive the standard systemic postoperative analgesic protocol used in all study groups. Total intravenous morphine consumption during the first 24 hours after surgery, measured in milligrams. Timepoint: From the end of surgery until 24 hours after surgery. Method of measurement: The cumulative dose of intravenous morphine administered as rescue analgesia during the first 24 hours after surgery will be recorded in milligrams using the medication administration record. Shahid Beheshti University of Medical Sciences Approved 2026-08-11 School of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee) Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor Tehran Tehran Iran (Islamic Republic of)