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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
294
Gas used for insufflation pressure
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).
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGMaximum 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."
Time frame: Postoperatively, before discharge from PACU (postoperative day 0)
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."
Time frame: 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."
Time frame: Immediately prior to discharge from PACU (postoperative day 0)
Inpatient morphine milligram equivalents
Daily total of opioid medications administered on the day of surgery
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
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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
From arrival to PACU to discharge home
Time frame: 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"
Time frame: 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).
Time frame: Intraoperative