Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06338865
Status
Recruiting
Apply to this trial

Conditions

  • Laparoscopic Surgery

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carbon dioxide — OTHER
    Gas used for insufflation pressure
  • Bupivacaine — DRUG
    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).
  • Oxycodone — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 3, 2024
Status verified
May 2024
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
294 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 15mmHg (Conventional Laparoscopic Arm)
    Standard Pressure, Conventional Laparoscopic Arm
  • Experimental: 12mmHg (Conventional Laparoscopic Arm)
    Lower Pressure, Conventional Laparoscopic Arm
  • Experimental: 10mmHg (Conventional Laparoscopic Arm)
    Lowest Pressure, Conventional Laparoscopic Arm
  • Active Comparator: 15mmHg (Robotic-Assisted Laparoscopic Arm)
    Standard Pressure, Robotic-Assisted Laparoscopic Arm
  • Experimental: 12mmHg (Robotic-Assisted Laparoscopic Arm)
    Lower Pressure, Robotic-Assisted Laparoscopic Arm
  • Experimental: 10mmHg (Robotic-Assisted Laparoscopic Arm)
    Lowest Pressure, Robotic-Assisted Laparoscopic Arm

Primary Outcome Measure

Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) [ Time Frame: Postoperatively, before discharge from PACU (postoperative day 0) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Rebecca Schneyer, MD
[email protected]
914-391-2604

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By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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