Single Port Insufflation RCT
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Details and patient eligibility
About
The goal of this clinical trial is to learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. The main question it aims to answer is:
Does minimally decreasing insufflation pressure improve postoperative pain?
Researchers will compare standard insufflation pressure (15 mmHg) to experimental insufflation pressure (12 mmHg) to see if it insufflation pressure impacts patient's postoperative pain.
Once a participants agrees to participate in our study, they will receive either standard or experimental pressure at the time of surgery. Postoperative pain scores in the postoperative anesthesia care unit and at postoperative day 1 and 14 visits will be recorded. Participants will also be asked to complete the Patient Global Impression of Improvement at the 14 day visit.
Full description
This was a double-blinded, randomized control trial of women undergoing single port robotic sacrocolpopexy with intraperitoneal insufflation pressure set to 15 mm Hg (standard pressure) or 12 mm Hg (experimental pressure). Participants were randomized in a 1:1 ratio. Randomization was performed by an unblinded research coordinator with stratification by concomitant hysterectomy. Robotic surgeries were performed with the DaVinci single port robotic system, which supports the use of an 8-mm AirSeal port. Preoperative pain score (2 hours prior to surgery) were documented by a member of the research team. The operating room circulating nurse set the insufflation pressure to either 12 or 15 mm Hg depending on randomization. Both the patient and surgeon were blinded to the insufflation pressure. In post anesthesia care unit , patient reported pain scores were documented by nursing staff. Median immediate postoperative pain score and total required morphine milligram equivalents (MME) were recorded. On postop day one, participants were be asked to rate their pain with a numeric rating scale by a registered nurse. At 2 weeks postoperatively, participants were asked to rate their pain with a numeric rating scale and completed the Patient Global Impression of Improvement. At both visits, the clinical team member asked the patient how many narcotic tablets they have left to calculate total MME use outpatient. The clinical team member conducting these visits was blinded to randomization groups. Pain scores and patient responses were collected as well as demographics, clinical characteristics, surgery details, intraoperative outcomes, and 2 week postoperative outcomes. The investigators estimate the median numeric rating scale score in the immediate postoperative period to be 75 mm in the standard insufflation pressure group based on prior literature. The investigators calculated that 32 patients in each group are needed to detect a significant improvement of median numeric rating scale score to 60 mm in the experimental group. The investigators planned to enroll at least 64 participants to have 80% power to detect a 15 mm difference in scores between the two groups assuming a two-sided significance level of 5%. Assuming a 10% drop out rate, a total sample of 70 participants was recruited.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult women scheduled for single port robotic sacrocolpopexy for uterovaginal or vaginal vault prolapse
Exclusion criteria
- Non-english speaking
- Inability to complete study questionnaires
Trial design
Primary purpose
Allocation
Interventional model
Masking
70 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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