Comparing standard and lower pressure in laparoscopic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how different insufflation pressures affect post-operative pain and surgical field visibility in patients undergoing laparoscopic gynecologic surgery. It is a single-center, single-blinded randomized controlled trial that will compare three groups with varying pressures: 15mmHg (standard), 12mmHg, and 10mmHg. Participants will be randomly assigned to one of the three groups, and the study will include both conventional and robotic-assisted laparoscopic procedures. The goal is to determine if lower pressures can reduce pain without compromising the surgical view.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Matthew Siedhoff, MD — Cedars-Sinai Medical Center
• Study coordinator: Rebecca Schneyer, MD
• Email: rebecca.schneyer@cshs.org
• Phone: 914-391-2604

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.