Investigation of oral Tizanidine on postoperative shoulder pain in laparoscopic cholecystectomy compared to the control group

Determining the effect of oral tizanidine on shoulder pain after laparoscopic cholecystectomy

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. The rand function of Excel software will be used for randomization.

This study will be conducted on patients at Aria Hospital in Mashhad in 2023The patients will be randomly divided into two groups with the help of a random number table. The patients will know about participating in the study, but they will not be aware of the drugs in groups A and B. The evaluators will not be aware of the contents of the groups. Before the operation, all patients will be informed about the use of the analog vision scale. (VAS) will be explained. The assessment of shoulder pain in patients will be based on a 10-point visual analog scale, so that the number 10 represents the worst (most severe) pain experienced by the patient and the number 0 represents no pain at the site. Patients are checked for pain at 2, 4, and 24 hours after surgery. The need for additional painkillers, which is the amount of opioid injections received (5 mg of morphine per injection), will also be calculated.

entry criteria:1- Patients undergoing elective laparoscopic cerebrocystectomy 2- Age between 18 and 65 years Non-entry criteria:1- People with contraindications to tizanidine prescription 2- Converting laparoscopic surgery to open surgery 3-Using opium

Intervention group: Patients will receive 4 mg of tizanidine orally dissolved in 50 ml of water 2 hours before anesthesia. Placebo group: They will receive 50 ml of pure water, which will be identical to the original drug in terms of appearance.

Dose of painkillers received; side effects of tizanidine;

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.

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.

Patient data after de-identification

The access period starts 6 months after the results are published

For all people

In case of coordination with the main person in charge, the use of data will be allowed

The main person responsible for the project: Dr. Hamed Beyzaii hmd_beyzaii@yahoo.com-09153106236

In case of submitting an official request by email or message on authorized virtual networks, a response will be given within ten working days.