Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Not Applicable

Recruiting

• Conditions: Laparoscopic Surgery
• Interventions: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

• Registration Number: NCT06338865
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-01
• Status Verified: 2024-05
• Study Start: 2024-05-03
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 294

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10mmHg (Robotic-Assisted Laparoscopic Arm)	Carbon dioxide	Lowest Pressure, Robotic-Assisted Laparoscopic Arm
15mmHg (Conventional Laparoscopic Arm)	Carbon dioxide	Standard Pressure, Conventional Laparoscopic Arm
15mmHg (Conventional Laparoscopic Arm)	Oxycodone	Standard Pressure, Conventional Laparoscopic Arm
12mmHg (Conventional Laparoscopic Arm)	Carbon dioxide	Lower Pressure, Conventional Laparoscopic Arm
12mmHg (Conventional Laparoscopic Arm)	Bupivacaine	Lower Pressure, Conventional Laparoscopic Arm
12mmHg (Robotic-Assisted Laparoscopic Arm)	Bupivacaine	Lower Pressure, Robotic-Assisted Laparoscopic Arm
10mmHg (Robotic-Assisted Laparoscopic Arm)	Bupivacaine	Lowest Pressure, Robotic-Assisted Laparoscopic Arm
12mmHg (Robotic-Assisted Laparoscopic Arm)	Carbon dioxide	Lower Pressure, Robotic-Assisted Laparoscopic Arm
15mmHg (Robotic-Assisted Laparoscopic Arm)	Carbon dioxide	Standard Pressure, Robotic-Assisted Laparoscopic Arm
10mmHg (Conventional Laparoscopic Arm)	Carbon dioxide	Lowest Pressure, Conventional Laparoscopic Arm
15mmHg (Conventional Laparoscopic Arm)	Bupivacaine	Standard Pressure, Conventional Laparoscopic Arm
10mmHg (Conventional Laparoscopic Arm)	Oxycodone	Lowest Pressure, Conventional Laparoscopic Arm
12mmHg (Conventional Laparoscopic Arm)	Oxycodone	Lower Pressure, Conventional Laparoscopic Arm
10mmHg (Conventional Laparoscopic Arm)	Bupivacaine	Lowest Pressure, Conventional Laparoscopic Arm
15mmHg (Robotic-Assisted Laparoscopic Arm)	Bupivacaine	Standard Pressure, Robotic-Assisted Laparoscopic Arm
15mmHg (Robotic-Assisted Laparoscopic Arm)	Oxycodone	Standard Pressure, Robotic-Assisted Laparoscopic Arm
12mmHg (Robotic-Assisted Laparoscopic Arm)	Oxycodone	Lower Pressure, Robotic-Assisted Laparoscopic Arm
10mmHg (Robotic-Assisted Laparoscopic Arm)	Oxycodone	Lowest Pressure, Robotic-Assisted Laparoscopic Arm

Primary Outcome Measures

Name	Time	Method
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)	Postoperatively, before discharge from PACU (postoperative day 0)	The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

Secondary Outcome Measures

Name	Time	Method
Total number of 5mg oxycodone pills taken in the 2 weeks following discharge	Assessed at postoperative day 14
First reported pain score in PACU (numerical rating scale, 0-10)	Immediately upon arrival to PACU (postoperative day 0)	The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Conversion to laparotomy	Intraoperative
Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)	Immediately prior to discharge from PACU (postoperative day 0)	The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Estimated blood loss	Intraoperative
Intraoperative complications	Intraoperative
Postoperative length of stay	Postoperatively, before discharge from PACU (postoperative day 0)	From arrival to PACU to discharge home
Need for adjustment of insufflation pressure	Intraoperative	In a post-op questionnaire, surgeons will indicate whether the insufflation pressure was adjusted at any point during the procedure (yes/no).
Operative time	Intraoperative
Surgeon-reported adequacy of assigned insufflation pressure	Immediately following surgery	Surgeons will rate their agreement with the following statement on a 5-point Likert scale (from strongly disagree to strongly agree): "The assigned insufflation pressure was adequate for this procedure"
Inpatient morphine milligram equivalents	Day of surgery (postoperative day 0)	Daily total of opioid medications administered on the day of surgery
Need for insufflation pressure increase intra-operatively due to inadequate visualization	Intraoperative

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States