Short Title: Standard vs. Lower Pressure Pneumoperitoneum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbon dioxide, Bupivacaine, Oxycodone.
- Who it may be relevant to
- Registry conditions: Laparoscopic Surgery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) [Time frame: Postoperatively, before discharge from PACU (postoperative day 0)]
Secondary outcome measures (12)
- First reported pain score in PACU (numerical rating scale, 0-10) [Time frame: Immediately upon arrival to PACU (postoperative day 0)]
- Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10) [Time frame: Immediately prior to discharge from PACU (postoperative day 0)]
- Inpatient morphine milligram equivalents [Time frame: Day of surgery (postoperative day 0)]
- Total number of 5mg oxycodone pills taken in the 2 weeks following discharge [Time frame: Assessed at postoperative day 14]
- Need for insufflation pressure increase intra-operatively due to inadequate visualization [Time frame: Intraoperative]
- Operative time [Time frame: Intraoperative]
- Estimated blood loss [Time frame: Intraoperative]
- Intraoperative complications [Time frame: Intraoperative]
- Conversion to laparotomy [Time frame: Intraoperative]
- Postoperative length of stay [Time frame: Postoperatively, before discharge from PACU (postoperative day 0)]
- Surgeon-reported adequacy of assigned insufflation pressure [Time frame: Immediately following surgery]
- Need for adjustment of insufflation pressure [Time frame: Intraoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT06338865 · Study00003146