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IRCT20230809059098N1 IRCT 2023-11-29 Akhtar Hospital Research Center Effect of Pregabalin on postoperative pain after anterior cruciate ligament (ACL) reconstruction The efficacy of Pregabalin compared to placebo in management of acute postoperative pain after anterior cruciate ligament (ACL) reconstruction surgery 2023-10-23 anticipated 132 Complete https://irct.ir/trial/73254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized clinical trial study, patients are placed in each of the two groups according to the simple randomization method in a 1:1 ratio. The assigned group for each person is notified to the surgeon by a sealed letter, Blinding description: In this double-blind study, patients are studied with random identification codes assigned to them by the researcher. Patients and the person in charge of data collection are blinded to the type of patient group. Patients will be unaware of which study group they are in. Both intervention and control groups receive similar recommendations. The person in charge of data collection will be unaware of the treatment group of each patient and will record the results only based on the identification code of the people. 2 Pain. Intervention 1: Intervention group: A single dose of pregabalin from Tehran Shimi Company, 150 mg, is taken 2 hours before surgery with a glass of water. Intervention 2: Control group: A single dose placebo (capsule containing sucrose with the same shape and color as pregabalin capsule) is taken with a glass of water 2 hours before surgery. Yes - There is a plan to make this available What will be shared: Collected deidentified IPD, IPD collected for the primary outcome measure only When: Deidentified data will be available starting from May, 2023. To whom: People working in academic institutions Conditions: No specific condition Where to obtain: Email Emad Kouhestani to obtain data emadkouhestani@gmail.com How to obtain: The process is: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided in one month. Comments:
public Emad Kouhestani
Sharifi Manesh street
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2260 1761 emadkouhestani@gmail.com Shahid Beheshti University of Medical Sciences scientific Emad Kouhestani
Sharifi Manesh street
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2260 1761 emadkouhestani@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 45 who undergo arthroscopy for anterior cruciate ligament reconstruction in Akhtar Hospital in 1402 are included in the study. 18 years 45 years Male Any known allergies or contraindications to pregabalin History of heart, kidney or liver disease Preoperative use of antidepressants or anticonvulsants History of drug or alcohol addiction Nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids use 48 hours before surgery Patients who underwent meniscus reconstruction or allografts were used M25.5 Pain in joint Treatment - Drugs Treatment - Drugs Intervention group: A single dose of pregabalin from Tehran Shimi Company, 150 mg, is taken 2 hours before surgery with a glass of water. Control group: A single dose placebo (capsule containing sucrose with the same shape and color as pregabalin capsule) is taken with a glass of water 2 hours before surgery. Postoperative pain. Timepoint: 6, 12, 24 hours postoperatively. Method of measurement: Numeric pain scale. Akhtar Hospital Research Center Approved 2023-10-18 Ethics committee of Shahid Beheshti University of Medical Sciences Shariati street Tehran Tehran Iran (Islamic Republic of)