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IRCT20260428069192N3 IRCT 2026-08-08 Tehran University of Medical Sciences Comparison of the Analgesic Effects of Topical Bupivacaine and Tramadol in Appendectomy Surgery Comparison of the Analgesic Effects of Surgical Site Bupivacaine and Tramadol Infiltration After Appendectomy 2026-08-11 anticipated 80 Recruiting https://irct.ir/trial/92179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: n this randomized controlled clinical trial, the Simple Randomization method using computer-generated random numbers will be employed(Uniform Random Number Generator). This method is a fully probabilistic (random) approach in which each participant has an entirely equal and independent chance of being allocated to either of the two intervention groups. In this method, the randomization sequence is designed in such a way that allocation of each patient to groups is not predictable in any way and is based solely on chance and probability. The probability of allocation to each group is 50% (1:1 ratio), Blinding description: In this study, blinding is designed as a double‑blind trial with the exception that the injecting physician is not blind, while the patient, data collector , and statistical analyst will all remain blind to the patient's group allocation. The study drugs (bupivacaine 0.25% and tramadol 100 mg dissolved in normal saline) will be prepared by an independent pharmacist in identical 20 mL syringes with clear and colorless appearance, and will be labeled only with group codes (A or B). After opening the randomization envelope, only the surgeon will be informed of the group code and will inject the corresponding drug at the surgical site. The patient, anesthesia team, nurses, and pain assessor will remain unaware of the injected drug type. The statistical analyst will receive data coded as A and B, and unblinding will be performed after analysis completion. To maintain blinding throughout the study, all team members are obligated to preserve blinding, and no information about the patient's group will be disclosed to the pain assessor or patient. In case of any accidental disclosure of the patient's group, this will be recorded as a "Breach of Blinding" in the data collection form and will be considered in the final analysis. 4 Acute postoperative pain resulting from appendectomy surgical incision. Intervention 1: Intervention group: After fascial closure and before skin closure, 20 mL of bupivacaine 0.25% (equivalent to 50 mg) will be infiltrated by the surgeon in a layer‑by‑layer, multi‑site manner at the surgical site. The injection technique is as follows: 5 mL injected into the muscle fascia, 10 mL injected into the subcutaneous tissue (in a fan‑shaped manner), and the remaining 5 mL injected into the subdermal layer. Injection will be performed slowly (approximately 2 mL per 10 seconds), and the wound will not be massaged after injection. Intervention 2: Control group: After fascial closure and before skin closure, 100 mg of tramadol hydrochloride dissolved in 20 mL of normal saline will be infiltrated by the surgeon in a layer‑by‑layer, multi‑site manner at the surgical site. The injection technique is identical to Group A: 5 mL injected into the muscle fascia, 10 mL injected into the subcutaneous tissue (in a fan‑shaped manner), and the remaining 5 mL injected into the subdermal layer. Injection will be performed slowly (approximately 2 mL per 10 seconds), and the wound will not be massaged after injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is All data will remain confidential in accordance with the ethical commitment, and only aggregated group-level results will be published in the form of a final article or report
public Mohamad Sorani
No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran.
Teran Iran (Islamic Republic of) 1417744361 +98 21 8898 3025 mohamad.sorani@gmail.com Tehran University of Medical Sciences scientific Mohamad Sorani
No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran.17
Tehran Iran (Islamic Republic of) 1417744361 +98 21 8898 3025 mohamad.sorani@gmail.com Tehran University of Medical Sciences Iraq Age between 18 and 65 years. Candidate for appendectomy under general anesthesia. ASA physical status class I or II according to American Society of Anesthesiologists criteria. Ability to fully understand the study protocol and provide written informed consent 18 years 65 years Both Known allergy or hypersensitivity to bupivacaine, tramadol, or any of the study medications. History of chronic opioid use or substance abuse. Severe cardiac, hepatic, renal, or advanced neurological disorders. Pregnancy or breastfeeding. Body Mass Index (BMI) greater than 35 kg/m². Diagnosis of perforated appendicitis or generalized peritonitis requiring extensive surgery. Inability to communicate effectively for reliable pain score assessment. K35 Acute appendicitis Treatment - Drugs Treatment - Drugs Intervention group: After fascial closure and before skin closure, 20 mL of bupivacaine 0.25% (equivalent to 50 mg) will be infiltrated by the surgeon in a layer‑by‑layer, multi‑site manner at the surgical site. The injection technique is as follows: 5 mL injected into the muscle fascia, 10 mL injected into the subcutaneous tissue (in a fan‑shaped manner), and the remaining 5 mL injected into the subdermal layer. Injection will be performed slowly (approximately 2 mL per 10 seconds), and the wound will not be massaged after injection. Control group: After fascial closure and before skin closure, 100 mg of tramadol hydrochloride dissolved in 20 mL of normal saline will be infiltrated by the surgeon in a layer‑by‑layer, multi‑site manner at the surgical site. The injection technique is identical to Group A: 5 mL injected into the muscle fascia, 10 mL injected into the subcutaneous tissue (in a fan‑shaped manner), and the remaining 5 mL injected into the subdermal layer. Injection will be performed slowly (approximately 2 mL per 10 seconds), and the wound will not be massaged after injection. Postoperative pain score measured by Visual Analog Scale (VAS) at PACU arrival and at 1, 2, 4, 6, 12, and 24 hours after surgery (0–10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain). Timepoint: PACU arrival and at 1, 2, 4, 6, 12, and 24 hours after surgery. Method of measurement: it will be measured by Visual Analog Scale (VAS)0–10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Total opioid consumption within the first 24 hours after surgery. Timepoint: within the first 24 hours after surgery. Method of measurement: Total opioid consumption after surgery in Milgram. Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, and Mean Arterial Pressure. Timepoint: PACU arrival, 30 minutes after surgery, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery. Method of measurement: Using standard monitoring devices (blood pressure monitor and electrocardiography) in the recovery unit and surgical ward. Time to First Rescue Analgesic Request. Timepoint: when the patient first requests analgesia or VAS reaches 4 or higher). Method of measurement: Recording of exact time (minutes) from the end of surgery (extubation) to analgesic request, based on nursing documentation and recorded in the data collection form. Tehran University of Medical Sciences Approved 2025-08-02 Research Ethics Committees of School of Public Health & Allied Medical Sciences- Tehran University No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)