Short Title: Standard vs. Lower Pressure Pneumoperitoneum
- Conditions
- Laparoscopic Surgery
- Interventions
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 294
- 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.
- 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