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IRCT20230607058402N1 IRCT 2023-08-23 Qazvin University of Medical Sciences Evaluation of the effectiveness of the Intraperitoneal Irrigation with tumescent solution on the intensity of postoperative pain in laparoscopic cholecystectomy patients Evaluation of the effectiveness of the Intraperitoneal Irrigation with tumescent solution on the intensity of postoperative pain in laparoscopic cholecystectomy patients 2023-07-01 anticipated 54 Complete https://irct.ir/trial/70591 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Laparoscopic cholecystectomy. Intervention 1: Intervention group: Intraperitoneal washing with Tamosent solution (group A): At the beginning of surgery and right after inflating the pneumoperitoneum and before any dissection of the gallbladder, the surgeon injects 200 ml of Tamosent solution (a mixture of 5 ampoules of 0.5% bupivacaine and one vial of 7.5% sodium bicarbonate in 450 ml of normal Saline) will be injected in the space under the diaphragm and the gallbladder area with the guidance of the camera. The patient was kept in the Trendelenburg position for 5 to 10 minutes. After that, the patients will be placed in the anti-Trendelenburg position to start the surgery, and the laparoscopic operation will be performed in a standard way, and the rest of the serum containing the Tamosent solution will be injected during the surgery and at the end of the operation. Intervention 2: Control group: Intraperitoneal lavage with normal saline alone (group B): After placing the laparoscopic ports, the patients will be placed in the anti-Trendelenburg position to start the surgery, and the laparoscopic operation will be performed in a standard way, and at the end of the operation, 500 ml of 0.9% normal saline will be used to wash the upper surface of the liver and below the surgical bed. A semi-right aperture will be used. After the removal of the gallbladder is completed in both groups, fluids will be completely aspirated before the pneumoperitoneum is drained. At the end of the surgery, CO2 is carefully drained by manually compressing the abdomen with open trocars (especially through the epigastric trocar) and the drain will not be used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Satisfaction of participants
public Amirarad mahmoudi
Bahonar street
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 amiraradmahmoudi@gmail.com Qazvin University of Medical Sciences scientific Amirarad Mahmoudi
University campus building, Bahonar Blvd
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 amiraradmahmoudi@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with symptomatic gallstones or chronic cholecystitis 25 years 70 years Both Pregnant women aged <25 years and >70 years emergency cholecystectomy jaundice intraoperative injury to the intestine or bile duct intraoperative bleeding gangrenous cholecystitis or emphysema obstructive jaundice choledocholithiasis coagulopathy gallbladder rupture during surgery or damage to the common bile duct cholangitis pancreatitis gallbladder carcinoma and its abnormalities previous upper abdominal surgery Unwillingness to participate in the study patients with a history of drug or alcohol abuse K80.0 Calculus of gallbladder with acute cholecystitis Treatment - Drugs Treatment - Drugs Intervention group: Intraperitoneal washing with Tamosent solution (group A): At the beginning of surgery and right after inflating the pneumoperitoneum and before any dissection of the gallbladder, the surgeon injects 200 ml of Tamosent solution (a mixture of 5 ampoules of 0.5% bupivacaine and one vial of 7.5% sodium bicarbonate in 450 ml of normal Saline) will be injected in the space under the diaphragm and the gallbladder area with the guidance of the camera. The patient was kept in the Trendelenburg position for 5 to 10 minutes. After that, the patients will be placed in the anti-Trendelenburg position to start the surgery, and the laparoscopic operation will be performed in a standard way, and the rest of the serum containing the Tamosent solution will be injected during the surgery and at the end of the operation. Control group: Intraperitoneal lavage with normal saline alone (group B): After placing the laparoscopic ports, the patients will be placed in the anti-Trendelenburg position to start the surgery, and the laparoscopic operation will be performed in a standard way, and at the end of the operation, 500 ml of 0.9% normal saline will be used to wash the upper surface of the liver and below the surgical bed. A semi-right aperture will be used. After the removal of the gallbladder is completed in both groups, fluids will be completely aspirated before the pneumoperitoneum is drained. At the end of the surgery, CO2 is carefully drained by manually compressing the abdomen with open trocars (especially through the epigastric trocar) and the drain will not be used. Intensity of postoperative pain. Timepoint: Assessment of shoulder and abdominal pain intensity at 6, 12 and 24 hours during 24 hours after surgery. Method of measurement: Visual Analog Score (VAS). Qazvin University of Medical Sciences Approved 2023-08-19 Ethics committee of qazvin University of Medical Sciences Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin Qazvin Qazvin Iran (Islamic Republic of)