OBJECTIVE:
To evaluate whether decreasing insufflation pressure reduces postoperative pain and opioid use in women undergoing robotic-assisted sacrocolpopexy.
METHODS:
In a single-blinded randomized trial, women with pelvic organ prolapse underwent robotic-assisted sacrocolpopexy at either 12 mm Hg (experimental) or 15 mm Hg (standard) insufflation pressure. The primary outcome was pain rating on a visual analog scale (VAS) on postoperative day 1 within 24 hours of surgery. Secondary outcomes included VAS pain rating at outpatient follow-up, inpatient and outpatient use of opioids, operative time, and estimated blood loss. A margin of 15 mm was considered clinically different on the VAS, and at 80% power, a sample size of at least 64 participants was needed to show significance.
RESULTS:
From April 27, 2021, to May 17, 2022, 80 women were enrolled, with 41 in the experimental group and 39 in the standard group. All participants underwent surgery as planned and attended a 2-week postoperative follow-up. Participants in the experimental group had less pain on postoperative day 1 with median VAS of 17.0 mm (interquartile range 26.0) compared with 29.0 mm (interquartile range 32.0, P=.007) in the standard group. No differences were noted in the secondary outcomes of operative time, estimated blood loss, or length of stay. Participants in the experimental group were noted to use fewer opioids while an inpatient (P=.04) and outpatient (P=.02). In multivariable analyses, lower insufflation pressure and increasing age were negatively associated with postoperative VAS scores.
CONCLUSION:
Lowering insufflation pressure (12 mm Hg) during robotic-assisted sacrocolpopexy safely reduced postoperative pain and opioid use compared with standard pressure (15 mm Hg).
CLINICAL TRIAL REGISTRATION:
ClinialTrials.gov, NCT 04858438.