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Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

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

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

Study details
    Laparoscopic Surgery

NCT06338865

Cedars-Sinai Medical Center

14 May 2024

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