Clinical trial NCT06338865: Short Title: Standard vs. Lower Pressure Pneumoperitoneum
Official title: Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: laparoscopic surgery
insufflation
pneumoperitoneum
gynecologic surgery
postoperative pain
robotic surgery
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization.

Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure:

1. Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
2. Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery.

The methodology for the two arms will be otherwise identical.

Eligibility 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

Primary outcomes:
measure: Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
timeFrame: Postoperatively, before discharge from PACU (postoperative day 0)
Secondary outcomes:
measure: First reported pain score in PACU (numerical rating scale, 0-10)
timeFrame: Immediately upon arrival to PACU (postoperative day 0)
measure: Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)
timeFrame: Immediately prior to discharge from PACU (postoperative day 0)
measure: Inpatient morphine milligram equivalents
timeFrame: Day of surgery (postoperative day 0)
measure: Total number of 5mg oxycodone pills taken in the 2 weeks following discharge
timeFrame: Assessed at postoperative day 14
measure: Need for insufflation pressure increase intra-operatively due to inadequate visualization
timeFrame: Intraoperative
measure: Operative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Intraoperative complications
timeFrame: Intraoperative
measure: Conversion to laparotomy
timeFrame: Intraoperative
measure: Postoperative length of stay
timeFrame: Postoperatively, before discharge from PACU (postoperative day 0)
measure: Surgeon-reported adequacy of assigned insufflation pressure
timeFrame: Immediately following surgery
measure: Need for adjustment of insufflation pressure
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Matthew Siedhoff, MD
role: PRINCIPAL_INVESTIGATOR
References: