Single Port Insufflation RCT
- Conditions
- Postoperative Pain Score
- Registration Number
- NCT06990750
- Lead Sponsor
- University of Chicago
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
- Adult women scheduled for single port robotic sacrocolpopexy for uterovaginal or vaginal vault prolapse
- Non-english speaking
- Inability to complete study questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Post anesthesia Care Unit Pain 0 mins-4 hours after surgery Immediate after surgery in the post anesthesia care unit (PACU), patients were asked to rate their pain using a 100 point numeric rating scale. The PACU nurse routine asked pain score with routine vitals. The median score was recorded.
- Secondary Outcome Measures
Name Time Method Postoperative day 14 morphine milligram equivalents 14 days after surgery At postoperative day 14 telemedicine visit, patients were asked how many tablets of narcotics they had taken since discharge. Morphine milligram equivalents was then recorded.
Patient Global Impression of Improvement 14 days after surgery At postoperative day 14 telemedicine visit, the patients were asked to complete the Patient Global Impression of Improvement. Answers were recorded.
Postoperative day one pain 24 hours after surgery On postoperative day one telephone call, patients were asked to rate their pain using a 100 point numeric rating scale by the clinical team member.
Postoperative day one morphine milligram equivalents 24 hours after surgery On postoperative day one telephone call, patients were asked how many tablets of narcotics they had taken since discharge. Morphine milligram equivalents was then recorded.
Postoperative day 14 pain 14 days after surgery At postoperative day 14 telemedicine visit, patients were asked to rate their pain using a 100 point numeric rating scale by the clinical team member.
Post anesthesia care unit morphine milligram equivalents 0 mins-4 hours The total amount of morphine milligram equivalents the patient received in PACU was recorded.
Trial Locations
- Locations (1)
The University of Chicago
🇺🇸Chicago, Illinois, United States
The University of Chicago🇺🇸Chicago, Illinois, United States