Short Title: Standard vs. Lower Pressure Pneumoperitoneum

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338865
• Other study ID #: Study00003146
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2024
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Cedars-Sinai Medical Center
• Contact: Rebecca Schneyer, MD
• Phone: 914-391-2604
• Email: rebecca.schneyer[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Pneumoperitoneum

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Inpatient morphine milligram equivalents	Daily total of opioid medications administered on the day of surgery	Day of surgery (postoperative day 0)
Secondary	Total number of 5mg oxycodone pills taken in the 2 weeks following discharge		Assessed at postoperative day 14
Secondary	Need for insufflation pressure increase intra-operatively due to inadequate visualization		Intraoperative
Secondary	Operative time		Intraoperative
Secondary	Estimated blood loss		Intraoperative
Secondary	Intraoperative complications		Intraoperative
Secondary	Conversion to laparotomy		Intraoperative
Secondary	Postoperative length of stay	From arrival to PACU to discharge home	Postoperatively, before discharge from PACU (postoperative day 0)
Secondary	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
Secondary	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