Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Laparoscopic Surgery

Treatments: Drug: Bupivacaine; Drug: Oxycodone; Other: Carbon dioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT06338865

Study00003146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 6 patient groups

15mmHg (Conventional Laparoscopic Arm)

Active Comparator group

Description:

Standard Pressure, Conventional Laparoscopic Arm

Treatment:

Drug: Bupivacaine

Other: Carbon dioxide

Drug: Oxycodone

12mmHg (Conventional Laparoscopic Arm)

Experimental group

Description:

Lower Pressure, Conventional Laparoscopic Arm

Treatment:

Drug: Bupivacaine

Other: Carbon dioxide

Drug: Oxycodone

10mmHg (Conventional Laparoscopic Arm)

Experimental group

Description:

Lowest Pressure, Conventional Laparoscopic Arm

Treatment:

Drug: Bupivacaine

Other: Carbon dioxide

Drug: Oxycodone

15mmHg (Robotic-Assisted Laparoscopic Arm)

Active Comparator group

Description:

Standard Pressure, Robotic-Assisted Laparoscopic Arm

Treatment:

Drug: Bupivacaine

Other: Carbon dioxide

Drug: Oxycodone

12mmHg (Robotic-Assisted Laparoscopic Arm)

Experimental group

Description:

Lower Pressure, Robotic-Assisted Laparoscopic Arm

Treatment:

Drug: Bupivacaine

Other: Carbon dioxide

Drug: Oxycodone

10mmHg (Robotic-Assisted Laparoscopic Arm)

Experimental group

Description:

Lowest Pressure, Robotic-Assisted Laparoscopic Arm

Treatment:

Drug: Bupivacaine

Other: Carbon dioxide

Drug: Oxycodone