Actively Recruiting
Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Led by Cedars-Sinai Medical Center · Updated on 2024-05-10
294
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different insufflation pressures affect post-operative pain and the quality of the surgical field during laparoscopic gynecologic surgery. This randomized controlled trial includes patients undergoing either conventional or robotic-assisted laparoscopic procedures. The study aims to see if lower pressures reduce pain right after surgery without affecting how well surgeons can see during the operation. Participants are randomly assigned to one of three groups based on insufflation pressure: standard pressure at 15mmHg, lower pressure at 12mmHg, or lowest pressure at 10mmHg. There are separate arms for conventional laparoscopic surgery and robotic-assisted laparoscopic surgery. All patients receive local anesthesia with bupivacaine at incision sites and are prescribed oxycodone pills for pain management after surgery. During the study, participants will have their post-operative pain assessed in the post-anesthesia care unit using a numerical rating scale. Researchers will also monitor surgical visualization, operative time, blood loss, complications, and opioid use up to two weeks after discharge. The study involves a single-blinded design with random allocation and will continue until April 2027.
CONDITIONS
Brief Title
Short Title: Standard vs. Lower Pressure Pneumoperitoneum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the duration of the study
- 18 years of age or older
- Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a minimally invasive gynecologic surgeon
You will not qualify if you...
- Pregnancy
- Urgent or non-scheduled surgery
- Planned or possible concurrent non-gynecologic surgery (e.g., urologic or colorectal procedure)
- Baseline opioid use
- Allergy or intolerance to bupivacaine, oxycodone, acetaminophen, or ibuprofen
- Planned post-operative hospital admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic gynecologic surgery with assigned insufflation pressure levels (15mmHg, 12mmHg, or 10mmHg) during the procedure. Local anesthesia with bupivacaine is administered, and oxycodone is prescribed for pain management after surgery.
1 surgery visit and monitoring during immediate post-operative care
Duration - 2 weeks
Participants are assessed for pain scores, opioid use, and surgical recovery during the two weeks following discharge from surgery.
1 follow-up visit at postoperative day 14
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
R
Rebecca Schneyer, MD
R
Rebekah Odum, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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