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IRCT20260517069425N1 IRCT 2026-10-31 Birjand University of Medical Sciences Evaluation of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block After Appendectomy Evaluation of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block After Appendectomy: A Controlled Clinical Trial Study 2026-09-23 anticipated 60 Recruiting https://irct.ir/trial/90245 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed at the individual patient level using simple computer-generated randomization, with an equal probability of assignment to either the intervention or control group. No blocking or stratification will be used. Before participant recruitment, an independent researcher who is not involved in participant enrollment or intervention delivery will generate the allocation sequence using a computerized pseudorandom number generator. For each position in the sequence, the program will independently generate either code 1 or code 2 with equal probability. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared according to the generated sequence by the independent researcher. Each envelope will contain one group assignment. After eligibility has been confirmed, written informed consent obtained, and baseline information recorded, each participant will receive the next sequential study number. The participant’s identifying details will be recorded on the corresponding envelope before it is opened. The envelope will then be opened by the anesthesiologist when the assigned intervention is due. Personnel responsible for participant enrollment will have no access to the allocation sequence or unopened assignments, Blinding description: This study will be conducted as a double-blind trial, with participants and data analysts blinded to group allocation. Both groups will undergo general anesthesia. Participants in the intervention group will receive a TAP block at the end of surgery before emergence from anesthesia, while participants in the control group will receive intravenous pethidine before transfer to the recovery room. Participants will not be informed of their assigned intervention. The anesthesiologist administering the intervention will be aware of group allocation. Statistical analyses will be performed without disclosing the treatment identity of each group to the data analysts. 3 Condition 1: Appendicitis. Condition 2: Acute postprocedural pain. Intervention 1: Intervention group (Transversus abdominis plane block with ropivacaine): At the end of open appendectomy, before emergence from general anesthesia, participants will receive a single right-sided transversus abdominis plane block administered by an anesthesiologist under ultrasound guidance using a lateral approach. Twenty milliliters of 0.25% ropivacaine will be injected between the internal oblique and transversus abdominis muscles. Intervention 2: Control group (Intravenous pethidine): Following open appendectomy under general anesthesia, participants will receive a single dose of 25 mg of intravenous pethidine before transfer to the recovery room. 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 Not decided yet.
public amirabbas esmaeilbeigi mahani
24th azar st,17 th alley, NO 15
kerman Iran (Islamic Republic of) 7619745549 +98 34 3245 0943 amires1375@gmail.com Birjand University of Medical Sciences scientific mohammadreza ghasemian
birjand.taleghani st,imam reza hospital
birjand Iran (Islamic Republic of) 1451451515 +98 56 3239 5812 dr.ghasemian54@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Age over 15 years ASA score 1 and 2 15 years no limit Both perforation appendicitis with hernia bowel surgery gynecology surgery with appendectomy age under 15 K35 G89.18 Acute appendicitis Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group (Transversus abdominis plane block with ropivacaine): At the end of open appendectomy, before emergence from general anesthesia, participants will receive a single right-sided transversus abdominis plane block administered by an anesthesiologist under ultrasound guidance using a lateral approach. Twenty milliliters of 0.25% ropivacaine will be injected between the internal oblique and transversus abdominis muscles. Control group (Intravenous pethidine): Following open appendectomy under general anesthesia, participants will receive a single dose of 25 mg of intravenous pethidine before transfer to the recovery room. Pain score. Timepoint: 1,2,6,12 and 24 hours post surgery. Method of measurement: NRS. Postoperative nausea/vomiting. Timepoint: At 1, 2, 6, 12, and 24 hours after completion of surgery. Method of measurement: Patient-reported nausea. Time from completion of surgery to the first request for rescue analgesia. Timepoint: At the first request for rescue analgesia during the first 24 hours after completion of surgery. Method of measurement: Recording the time of surgery completion and the time of the patient's first request for rescue analgesia on the data collection form. Cumulative postoperative opioid analgesic consumption. Timepoint: Cumulatively over the first 24 hours after completion of surgery. Method of measurement: Recording the name, route of administration, and dose of each opioid analgesic administered during the first 24 postoperative hours on the data collection form. Birjand University of Medical Sciences Approved 2025-12-24 ethics committee of birjand univercity of medical sciences kerman,24th azar st,17th alley,NO 15 birjand South Khorasan Iran (Islamic Republic of)