Recruiting

Standard vs. Lower Pressure

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06338865

Conditions

Laparoscopic Surgery

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carbon dioxide

Bupivacaine

Oxycodone

Study Details

Brief 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.

Conditions

Laparoscopic Surgery

Study ID

NCT06338865

Start date

May 3, 2024

Status verified date

May, 2024

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

294 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Carbon dioxide

Gas used for insufflation pressure

Bupivacaine

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

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.

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 and Locations

Central contacts

Rebecca Schneyer, MD

914-391-2604rebecca.schneyer@cshs.org

Rebekah Odum, BSN

rebekah.odum@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Rebecca Schneyer, MD

914-391-2604rebecca.schneyer@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

May 10, 2024

Last verified

May, 2024

Keywords

  • laparoscopic surgery
  • insufflation
  • pneumoperitoneum
  • gynecologic surgery
  • postoperative pain
  • robotic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2024-05-10.