Evaluation of the effectiveness of the Intraperitoneal Irrigation with tumescent solution on the intensity of postoperative pain in laparoscopic cholecystectomy patients

Determining the effectiveness of intraperitoneal washing with Tamosent solution on postoperative pain intensity in laparoscopic cholecystectomy patients

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, 25 samples in each group, which includes 10% dropout during the study, and the number of samples for each group is 27. Allocation of samples to intervention groups is done using 6 random blocks method

Patients with symptomatic gallstones who refer to Velayat hospital and are candidates for laparoscopic cholecystectomy according to the order of the patient's surgeon. In group A, the surgeon will inject 200 ml of Tamosent solution in the space below the diaphragm and the gallbladder area under the guidance of a camera. did In group B, at the end of the operation, 500 ml of 0.9% normal saline will be used to wash the surgical bed, the upper surface of the liver and the right half of the diaphragm.

Inclusion criteria: Patients of any age, sex, or occupation who are diagnosed with symptomatic gallstones or chronic cholecystitis. Exit criteria: pregnant women, age <25 years and >70 years, emergency cholecystectomy, intraoperative injury to the intestine or bile duct, intraoperative bleeding, gangrenous or emphysematous cholecystitis, obstructive jaundice. , choledocholithiasis, coagulopathy, rupture of the gallbladder during surgery or damage to the common bile duct, cholangitis, pancreatitis, carcinoma of the gallbladder and its abnormalities, previous upper abdominal surgery, and patients with a history of abuse Drugs or alcohol.

Intraperitoneal lavage with Tamosent solution (intervention group) and intraperitoneal lavage with normal saline alone (control group)

Severity of pain after surgery

This study is a double-blind randomized clinical trial that is conducted in patients with symptomatic gallstones who refer to educational-therapeutic centers in the province and are candidates for laparoscopic cholecystectomy according to the order of the surgeon. Using the method of random blocks (Balance block randomization), they are assigned to two treatment groups A and B, the balanced randomization method for the participants in the randomized controlled clinical trial study of intraperitoneal lavage with Tamosent solution (group A) and intraperitoneal lavage with normal saline alone (group B) on postoperative pain intensity in laparoscopic cholecystectomy patients.

Checklist information is provided by the secretary of the department in which people with national code are registered to the person responsible for the analysis and statistical analysis of the plan. After entering SPSS and coding 1 and 2, the results of the evaluation will be analyzed by the statistics professor, separated into intervention and control groups (which only the secretary of the department knows about). It is not known which washing method it received. The analyst and the data safety monitoring committee are not aware of which solution the patients received.