Short Title: Standard vs. Lower Pressure Pneumoperitoneum
ConditionLaparoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCedars-Sinai Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Urgent/non-scheduled surgery
Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
Baseline opioid use
Trial design
Design model
Parallel
Treatments tested in this trial
Carbon dioxide
Other interventionGas used for insufflation pressure
Bupivacaine
DrugLocal 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
DrugAll 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.
Treatment groups
294 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 15mmHg (Conventional Laparoscopic Arm)Active comparator 3 interventions
Group B: 12mmHg (Conventional Laparoscopic Arm)Experimental treatment 3 interventions
Group C: 10mmHg (Conventional Laparoscopic Arm)Experimental treatment 3 interventions
Group D: 15mmHg (Robotic-Assisted Laparoscopic Arm)Active comparator 3 interventions
Group E: 12mmHg (Robotic-Assisted Laparoscopic Arm)Experimental treatment 3 interventions
Group F: 10mmHg (Robotic-Assisted Laparoscopic Arm)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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."
Time frame
Postoperatively, before discharge from PACU (postoperative day 0)Secondary outcomes
1
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)2
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)3
Inpatient morphine milligram equivalents
Daily total of opioid medications administered on the day of surgery
Time frame
Day of surgery (postoperative day 0)4
Total number of 5mg oxycodone pills taken in the 2 weeks following discharge
Time frame
Assessed at postoperative day 14Sponsors and contacts
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Source ClinicalTrials.gov