Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol.

BACKGROUND: Laparoscopic cholecystectomy is the gold standard for treating symptomatic gallstone disease. Pneumoperitoneum is essential for adequate visualization during the procedure and is typically maintained at a standard pressure of 12-14 mmHg. However, high insufflation pressure may contribute to increased postoperative pain. This study aims to assess whether low-pressure pneumoperitoneum (8 mmHg) reduces postoperative pain compared to standard pressure (14 mmHg), without compromising operative safety or efficacy. We hypothesize that low pressure pneumoperitoneum at 8 mmHg reduces postoperative pain, without increasing operation time or postoperative morbidity. METHODS: This is a single-center, randomized, controlled, double-blind trial. Consecutive Adult patients scheduled for elective laparoscopic cholecystectomy will be randomized in a 1:1 ratio to receive either low-pressure (8 mmHg) or standard-pressure (14 mmHg) pneumoperitoneum. The primary outcome is postoperative abdominal pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include VAS pain scores at 12 and 24 hours, postoperative nausea and/or vomiting, postoperative hospital stay and postoperative 30-day morbidity. The enrollment of patients will be done between November 12, 2024 to December 31, 2025. TRIAL REGISTRATION: ClinicalTrials.gov NCT06685250. CONCLUSION: If proven effective, low-pressure pneumoperitoneum may represent a simple strategy to improve postoperative comfort in laparoscopic cholecystectomy without compromising surgical outcomes.