Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Other: Carbon dioxide; Drug: Bupivacaine; Drug: Oxycodone

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 Type: Interventional
• Enrollment (Estimated): 294
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Schneyer, MD; Phone Number: 914-391-2604; Email: rebecca.schneyer@cshs.org
• Study Contact Backup: Name: Rebekah Odum, BSN; Email: rebekah.odum@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Rebecca Schneyer, MD; Phone Number: 914-391-2604; Email: rebecca.schneyer@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)	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."	Postoperatively, before discharge from PACU (postoperative day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time		Intraoperative
Estimated blood loss		Intraoperative
First reported pain score in PACU (numerical rating scale, 0-10)	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."	Immediately upon arrival to PACU (postoperative day 0)
Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)	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."	Immediately prior to discharge from PACU (postoperative day 0)
Inpatient morphine milligram equivalents	Daily total of opioid medications administered on the day of surgery	Day of surgery (postoperative day 0)
Total number of 5mg oxycodone pills taken in the 2 weeks following discharge		Assessed at postoperative day 14
Need for insufflation pressure increase intra-operatively due to inadequate visualization		Intraoperative
Intraoperative complications		Intraoperative
Conversion to laparotomy		Intraoperative
Postoperative length of stay	From arrival to PACU to discharge home	Postoperatively, before discharge from PACU (postoperative day 0)
Surgeon-reported adequacy of assigned insufflation pressure	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"	Immediately following surgery
Need for adjustment of insufflation pressure	In a post-op questionnaire, surgeons will indicate whether the insufflation pressure was adjusted at any point during the procedure (yes/no).	Intraoperative

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Matthew Siedhoff, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: gynecologic surgery; laparoscopic surgery; postoperative pain; insufflation; pneumoperitoneum; robotic surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Oxycodone
• Other Study ID Numbers: Study00003146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No