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IRCT20231120060124N1 IRCT 2023-12-19 Qazvin University of Medical Sciences Investigating the effect of intra-abdominal CO2 gas pressure on shoulder pain after laparoscopic cholecystectomy Comparison of the effect of standard gas pressure with low intra-abdominal co2 pressure on postoperative shoulder pain in laparoscopic cholecystectomy patients 2023-12-22 anticipated 34 Complete https://irct.ir/trial/73957 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: This is a triple-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome and Data Safety and Monitoring Committee. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group. 3 Shoulder pain after laparoscopy. Intervention 1: Intervention group: a 10 mm port is inserted through the incision below the umbilicus using the Hasson method, and the abdominal cavity is filled with CO2 gas in group B with a low intra-abdominal pressure of 7-7 mm Hg, and the camera is also inserted into the abdomen through the same port. Under the camera guide, another 10 mm port will be placed under the xiphoid process and two 5 mm ports in the subcostal area. During the process of creating pneumoperitoneum, intra-abdominal pressure, gas volume and gas flow rate are checked, and gallbladder removal will be performed in group B with a low intra-abdominal pressure of 7-8 mmHg. The air behind the liver is completely sucked. Intervention 2: A 10 mm port is inserted through the incision below the umbilicus using the Hasson method, and the abdominal cavity is filled with CO2 gas in group A with a standard intra-abdominal pressure of 14-15 mm Hg, and the camera is also inserted into the abdomen through the same port under the camera guide. Another 10 mm port will be placed under the xiphoid appendage and two 5 mm ports will be placed in the subcostal region. During the process of creating pneumoperitoneum, intra-abdominal pressure, gas volume and gas flow rate are checked, and gallbladder removal will be performed in group A with a standard intra-abdominal pressure of 14-15 mmHg. The air behind the liver is completely sucked. 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 Alireza Abadi
Bahonar street
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 dralireza.abadi@gmail.com Qazvin University of Medical Sciences scientific Alireza Abadi
University campus building, Bahonar Blvd
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 dralireza.abadi@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients aged 25 to 70 who are 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 rupture of the gallbladder during Surgery or damage to the common bile duct cholangitis pancreatitis gallbladder carcinoma and its abnormalities previous upper abdominal surgery patients who do not want to participate in the study acute cholecystitis problems Nerves and psyche failure of the surgeon to use CO2 pressure M25.5 Pain in joint Treatment - Surgery Treatment - Surgery Intervention group: a 10 mm port is inserted through the incision below the umbilicus using the Hasson method, and the abdominal cavity is filled with CO2 gas in group B with a low intra-abdominal pressure of 7-7 mm Hg, and the camera is also inserted into the abdomen through the same port. Under the camera guide, another 10 mm port will be placed under the xiphoid process and two 5 mm ports in the subcostal area. During the process of creating pneumoperitoneum, intra-abdominal pressure, gas volume and gas flow rate are checked, and gallbladder removal will be performed in group B with a low intra-abdominal pressure of 7-8 mmHg. The air behind the liver is completely sucked. A 10 mm port is inserted through the incision below the umbilicus using the Hasson method, and the abdominal cavity is filled with CO2 gas in group A with a standard intra-abdominal pressure of 14-15 mm Hg, and the camera is also inserted into the abdomen through the same port under the camera guide. Another 10 mm port will be placed under the xiphoid appendage and two 5 mm ports will be placed in the subcostal region. During the process of creating pneumoperitoneum, intra-abdominal pressure, gas volume and gas flow rate are checked, and gallbladder removal will be performed in group A with a standard intra-abdominal pressure of 14-15 mmHg. The air behind the liver is completely sucked. Shoulder pain. Timepoint: 3, 6, 12 and 24 hours after the operation. Method of measurement: visual analog score (VAS). Qazvin University of Medical Sciences Approved 2023-10-15 Ethics committee of qazvin University of Medical Sciences Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd Qazvin Qazvin Iran (Islamic Republic of)