Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Not Applicable

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT04858438
• Lead Sponsor: Ascension South East Michigan

Brief Summary

This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

Detailed Description

This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine \& Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-02
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-20
• Last Update Submitted: 2021-04-23
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-27
• Primary Completion: 2022-05-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse.
• Age 18-90 years
• Can read and understand the consent form and consents to the procedure

Exclusion Criteria

• Patients undergoing other procedures
• Patients who do not consent to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.	Safety will be assessed at the two-week follow-up visit.	The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.	Pain will be assessed at the two-week post-operative follow-up visit.	Pain will be assessed during the two-week post-operative period.

Trial Locations

Locations (1)

Ascension St. John Hospital; 🇺🇸 Detroit, Michigan, United States