Clinical trial NCT06990750: Single Port Insufflation RCT
Official title: Insufflation Pressure and Postoperative Pain After Single Port Robotic Sacrocolpopexy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Score
Keywords: insufflation pressure
postoperative pain
surgeon visualization
robotic sacrocolpopexy
single port sacrocolpopexy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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. We 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. We 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. We 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post anesthesia Care Unit Pain
timeFrame: 0 mins-4 hours after surgery
Secondary outcomes:
measure: Post anesthesia care unit morphine milligram equivalents
timeFrame: 0 mins-4 hours
measure: Postoperative day one pain
timeFrame: 24 hours after surgery
measure: Postoperative day one morphine milligram equivalents
timeFrame: 24 hours after surgery
measure: Postoperative day 14 pain
timeFrame: 14 days after surgery
measure: Postoperative day 14 morphine milligram equivalents
timeFrame: 14 days after surgery
measure: Patient Global Impression of Improvement
timeFrame: 14 days after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Margaret G Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References: