Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Status Not yet recruiting

Clinical Trial Summary

This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.

Clinical Trial Description

This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization. Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure: 1. Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery 2. Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery. The methodology for the two arms will be otherwise identical. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06338865
Study type	Interventional
Source	Cedars-Sinai Medical Center
Contact	Rebecca Schneyer, MD
Phone	914-391-2604
Email	rebecca.schneyer@cshs.org
Status	Not yet recruiting
Phase	N/A
Start date	April 2024
Completion date	April 2027

View Details

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