Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Purpose

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.

Condition

  • Laparoscopic Surgery

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Patients and post-anesthesia care unit nurses will be masked.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
15mmHg (Conventional Laparoscopic Arm) 		Standard Pressure, Conventional Laparoscopic Arm
  • Other: Carbon dioxide
    Gas used for insufflation pressure
  • Drug: 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).
  • Drug: 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.
Experimental
12mmHg (Conventional Laparoscopic Arm) 		Lower Pressure, Conventional Laparoscopic Arm
  • Other: Carbon dioxide
    Gas used for insufflation pressure
  • Drug: 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).
  • Drug: 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.
Experimental
10mmHg (Conventional Laparoscopic Arm) 		Lowest Pressure, Conventional Laparoscopic Arm
  • Other: Carbon dioxide
    Gas used for insufflation pressure
  • Drug: 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).
  • Drug: 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.
Active Comparator
15mmHg (Robotic-Assisted Laparoscopic Arm) 		Standard Pressure, Robotic-Assisted Laparoscopic Arm
  • Other: Carbon dioxide
    Gas used for insufflation pressure
  • Drug: 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).
  • Drug: 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.
Experimental
12mmHg (Robotic-Assisted Laparoscopic Arm) 		Lower Pressure, Robotic-Assisted Laparoscopic Arm
  • Other: Carbon dioxide
    Gas used for insufflation pressure
  • Drug: 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).
  • Drug: 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.
Experimental
10mmHg (Robotic-Assisted Laparoscopic Arm) 		Lowest Pressure, Robotic-Assisted Laparoscopic Arm
  • Other: Carbon dioxide
    Gas used for insufflation pressure
  • Drug: 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).
  • Drug: 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.

Recruiting Locations

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Rebecca Schneyer, MD
914-391-2604
rebecca.schneyer@cshs.org

More Details

Status
Recruiting
Sponsor
Cedars-Sinai Medical Center

Study Contact

Rebecca Schneyer, MD
914-391-2604
rebecca.schneyer@cshs.org

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.