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NCT06338865NARecruiting

Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Cedars-Sinai Medical Center

Start Date

5/3/2024

Completion Date

4/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * 18 years of age or older * Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division. Exclusion Criteria: * Pregnancy * Urgent/non-scheduled surgery * Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure) * Baseline opioid use * Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen * Planned post-operative admission

Interventions

OTHER

Carbon dioxide

DRUG

Bupivacaine

DRUG

Oxycodone

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Conditions

Laparoscopic Surgery

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States