Comparing standard and lower pressure in laparoscopic surgery
Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
This study is testing if using lower pressure during laparoscopic gynecologic surgery can help reduce post-operative pain while still allowing doctors to see clearly during the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06338865 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for laparoscopic gynecologic surgery at Cedars-Sinai Medical Center.
Not a fit: Patients who are pregnant, undergoing urgent surgery, or have certain allergies or baseline opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced post-operative pain for patients undergoing laparoscopic gynecologic surgery.
How similar studies have performed: Other studies have explored varying insufflation pressures in laparoscopic surgery, but this specific approach is novel in its focus on gynecologic procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.