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IRCT20250731066712N1 IRCT 2025-08-03 Karaj University of Medical Sciences Local Ropivacaine Injection for Postoperative Pain Reduction in Patients Undergoing Kocher's Incision Investigating the Efficacy of Local Injection of Ropivacaine on Postoperative Pain in Patients Undergoing Kocher's Incision: A Randomized Clinical Trial 2025-08-11 anticipated 48 Complete https://irct.ir/trial/85236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A block randomization method with a block size of 4 and a 1:1 allocation ratio was used to assign participants to either the intervention (ropivacaine) or control (normal saline) group. The randomization list was generated using Random Allocation Software by an independent statistician who was not involved in the recruitment, intervention, or outcome assessment. To ensure balanced group sizes over time, random permutations of block sequences (e.g., AABB, ABAB, BBAA, etc.) were used. Each allocation code was sealed in an opaque, sealed, and sequentially numbered envelope. These envelopes were prepared by a third party blinded to the study objectives and group assignments. Upon enrollment and informed consent, the operating room nurse opened the next envelope in sequence to determine the assigned intervention, which was then administered accordingly, Blinding description: This study was conducted in a double-blind manner, meaning that both the patients and the outcome assessor were blinded to group allocation. Ropivacaine and placebo (0.9% normal saline) solutions were indistinguishable in volume, color, and appearance. The study medications were prepared in identical, unlabeled syringes by a third party not involved in the trial. Each syringe was marked with a code and administered by an anesthetic nurse or operating room staff unaware of the allocation at the end of the procedure. Postoperative pain assessment was performed by a nurse blinded to the treatment group. Group assignments were concealed until data analysis was complete. 3 Postoperative pain, Kocher’s incision, local ropivacaine infiltration, postoperative pain management. Intervention 1: Control group: At the end of surgery, patients in the control group will receive a subcutaneous injection of 20 mL of 0.9% normal saline in the same manner. The injection will be administered around the Kocher’s incision site, with 10 mL injected along the upper edge and 10 mL along the lower edge of the incision. Intervention 2: Intervention group: At the end of surgery, patients in the intervention group will receive a subcutaneous injection of 20 mL of ropivacaine solution at a concentration of 5 mg/mL, diluted to 20 mL. The injection will be administered evenly around the Kocher’s incision site, with 10 mL injected along the upper edge and 10 mL along the lower edge of the incision. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals. When: The access period starts 6 months after the results are published. To whom: Only for researchers working in academic and scientific institutions Conditions: The use of documents for research and scientific work is allowed. Where to obtain: Applicants should contact the following email to use and receive documents: nastaran.h.shiroudi@gmail.com How to obtain: In a period of less than two weeks, the applicants for receiving the documents who contacted by e-mail will be answered and the documents will be provided to them. Comments:
public Nastaran Hossein Shiroudi
Mahan boulevard, Madani square, Madani Hospital
Karaj Iran (Islamic Republic of) 3143744693 +98 26 3442 7001 nastaran.h.shiroudi@gmail.com Karaj University of Medical Sciences scientific Mohammad Hadi Bahri
Mahan boulevatd, Madani square, Madani Hospital
Karaj Iran (Islamic Republic of) 3143744693 +98 26 3442 7001 mh.bahri.۶۷@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Indication for surgery with Kocher’s incision Signed informed consent ASA class I–II Age 18 to 65 years Weight between 45 and 100 kg No known allergy to local anesthetics No severe cardiovascular, renal, or hepatic comorbidities 18 years 65 years Both Allergy to local anesthetics Patient’s refusal to continue participation at any stage Unexpected complications during surgery Conversion to laparoscopic or other surgical approaches K80-K87 Disorders of gallbladder, biliary tract and pancreas Treatment - Drugs Treatment - Drugs Control group: At the end of surgery, patients in the control group will receive a subcutaneous injection of 20 mL of 0.9% normal saline in the same manner. The injection will be administered around the Kocher’s incision site, with 10 mL injected along the upper edge and 10 mL along the lower edge of the incision. Intervention group: At the end of surgery, patients in the intervention group will receive a subcutaneous injection of 20 mL of ropivacaine solution at a concentration of 5 mg/mL, diluted to 20 mL. The injection will be administered evenly around the Kocher’s incision site, with 10 mL injected along the upper edge and 10 mL along the lower edge of the incision. Postoperative pain intensity at the surgical incision site. Timepoint: Measurement of pain intensity at the surgical incision site at 2, 6, 12, and 24 hours after surgery. Method of measurement: Measurement of pain intensity using the Visual Analogue Scale (pain ruler). Amount of analgesic medication used after surgery. Timepoint: Amount of analgesic medication used during the first 24 hours after surgery. Method of measurement: Calculation of the total milligrams of analgesic medication administered orally or intravenously, extracted from the patient's medical records. Karaj University of Medical Sciences Approved 2025-07-13 Ethics committee of Alborz University of Medical Sciences Mahan boulevard, Madani square, Madani Hospital Karaj Alborz Iran (Islamic Republic of)