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Study Comparing Low and Standard Pressure Pneumoperitoneum Effects on Shoulder Pain After Benign Gynecologic Laparoscopic Surgery
Led by Mount Sinai Hospital, Canada · Updated on 2025-07-31
82
Participants Needed
1
Research Sites
9 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of low pressure 10 mm Hg versus standard pressure 15 mm Hg pneumoperitoneum during benign gynecologic laparoscopic surgery. This single-center, double-blind randomized controlled trial aims to understand how these pressures influence post-operative shoulder tip pain, with the primary focus on pain measured one day after surgery. The study also looks at secondary outcomes including pain at earlier time points, quality of recovery, nausea, bloating, medication use, and surgical factors such as time and blood loss. Participants will be randomly assigned to one of two groups one receiving standard pressure pneumoperitoneum and the other receiving low pressure pneumoperitoneum. The pressure setting will be maintained throughout the surgery, and the surgical team will remain blinded to which pressure is being used. Standard peri-operative care will be provided to all patients. The study will collect data on pain, recovery quality, medication use, surgical visibility, anesthetist satisfaction, and any complications or adverse effects. Participants will be monitored for post-operative pain, nausea, and medication use while in the recovery unit and contacted on the first day after surgery for further pain assessments and recording of narcotic consumption. Researchers will also collect information on surgical time, blood loss, and any complications. The total participation involves surgery day assessments and follow-up phone contact on post-operative day one. The study aims to provide detailed information about recovery and pain management following gynecologic laparoscopic procedures.
CONDITIONS
Brief Title
Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
Research Team
S
Sara Hojabri, MBBCHBAO
M
Mara Sobel, MD, MSC
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