RecruitingNot ApplicableNCT06338865

Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial


Sponsor

Cedars-Sinai Medical Center

Enrollment

294 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • years of age or older
  • Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.

Exclusion Criteria6

  • 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

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Interventions

OTHERCarbon dioxide

Gas used for insufflation pressure

DRUGBupivacaine

Local subcutaneous infiltration of all port sites with 0.25% bupivacaine will be performed prior to each incision. Remaining local anesthetic will be administered into the incision sites prior to the conclusion of the case (30cc total).

DRUGOxycodone

All patients will be prescribed a total of 10 pills of oxycodone 5mg, which is the standard amount that our practice prescribes for patients after laparoscopic surgery.


Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT06338865


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