]>
IRCT20230726058933N1 IRCT 2023-09-05 Islamic Azad University Investigating the effect of oral tizanidine on shoulder pain Investigation of oral Tizanidine on postoperative shoulder pain in laparoscopic cholecystectomy compared to the control group 2023-09-23 anticipated 50 Complete https://irct.ir/trial/71793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Qualified participants will be randomly divided into control and treatment groups, and the individuals who refer will be divided using random numbers generated by the computer. In this way, on the Google randomization site To the address: https://www.google.com/search?q=random+number , the number will be between 1 and 2 clicks. If 1 patient is assigned to the treatment group and 2 patients are assigned to the control group, this study follows a double-blind design, in which the participants and the research team involved in data collection, analysis, and interpretation compared to The treatment allocations will be blind to the control group, a drug that will be completely similar to the main drug will be injected into the patients, and the information of both groups will be available to the research team as data A and B. Blinding during the study to minimize bias and ensure The integrity of the results will be maintained, Blinding description: In this double-blind research, the patients will be informed about participating in a study plan before the surgery, and it will be explained to the patients that they will be placed in two groups, but they will not be informed about being placed in the intervention and placebo groups, and they will be divided into groups A and B. The evaluators will also There are people who have not observed the patients before the operation, during the operation and during the drug injection, and then they complete the necessary checklists by being present at the bedside of patients of groups A and B. 3 Shoulder pain after laparoscopic cystectomy. Intervention 1: Intervention group: 2 hours before general anesthesia for surgery, the patients will receive one dose of Tizanidine, prepared by Actoverco (Actoverco) under the brand name Tizanover, one capsule of 4 mg will be dissolved in 50 ml of water and will be given to the patients. Intervention 2: Control group: They will receive the placebo in the form of 50 ml of pure water, which will be the same as the original drug in terms of appearance. Yes - There is a plan to make this available What will be shared: Patient data after de-identification When: The access period starts 6 months after the results are published To whom: For all people Conditions: In case of coordination with the main person in charge, the use of data will be allowed Where to obtain: The main person responsible for the project: Dr. Hamed Beyzaii hmd_beyzaii@yahoo.com-09153106236 How to obtain: In case of submitting an official request by email or message on authorized virtual networks, a response will be given within ten working days. Comments:
public Hamed Beyzaii
Mashhad - Golestan Street - Golestan Sharghi 5
Mashhad Iran (Islamic Republic of) 9513633938 +98 51 3222 9094 hmd_beyzaii@yahoo.com Islamic Azad University scientific Hamed Beyzaii
Mashhad - Golestan Street - Golestan Sharghi 5
Mashhad Iran (Islamic Republic of) 9513633938 +98 51 3222 9094 hmd_beyzaii@yahoo.com Islamic Azad University Iran (Islamic Republic of) Patients who undergo elective laparoscopic cholecystectomy surgery will be included in the study Patients must be between 18 and 65 years old 18 years 65 years Both Patients whose surgery was changed from laparoscopy to laparotomy Patients who are allergic to tizanidine Patients who take opium Treatment - Drugs Placebo Intervention group: 2 hours before general anesthesia for surgery, the patients will receive one dose of Tizanidine, prepared by Actoverco (Actoverco) under the brand name Tizanover, one capsule of 4 mg will be dissolved in 50 ml of water and will be given to the patients. Control group: They will receive the placebo in the form of 50 ml of pure water, which will be the same as the original drug in terms of appearance. Shoulder pain. Timepoint: 2, 4 and 24 hours after surgery. Method of measurement: visual analogue scale. Dose of painkillers received. Timepoint: With each injection in case of pain. Method of measurement: Number of injections. Side effects of tizanidine. Timepoint: 2, 4 and 24 hours after surgery. Method of measurement: Ask the patient. Islamic Azad University Approved 2023-06-28 Ethics Committee of Medical Faculty of Islamic Azad University - Mashhad Medical Sciences Unit 14 Imam Khomeini-Imam Khomeini Street (Sarab Alley) - Dr. Mohammad Shahin Far Medical Faculty Mashhad Razavi Khorasan Iran (Islamic Republic of)