Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Insufflation during surgery

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriella Rustia, MD; Phone Number: 313-343-6708; Email: gabriella.rustia@ascension.org
• Study Contact Backup: Name: Muhammad F Aslam, MD; Phone Number: 313-343-3494; Email: muhammad.aslam@ascension.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Recruiting
      • Ascension St. John Hospital
      • Contact: Gabriella M Rustia, MD; Email: gabriella.rustia@ascension.org
      • Contact: Muhammad F Aslam, MD; Email: muhammad.aslam@ascension.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Insufflation Group; Patients will receive standard insufflation during surgery (15 mm Hg).	Procedure: Insufflation during surgery; This is the amount of insufflation using during the surgical procedure.
Experimental: Low Insufflation Group; Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).	Procedure: Insufflation during surgery; This is the amount of insufflation using during the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.	Pain will be assessed during the 24-hour post-operative period.	Pain will be assessed within 24 hours of the surgery. .
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.	Pain will be assessed during the two-week post-operative period.	Pain will be assessed at the two-week post-operative follow-up visit.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.	The safety of the lower insufflation pressure will be assessed during the procedure.	Safety will be assessed during the procedure.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.	The safety of the lower insufflation pressure will be assessed immediately post-operatively.	Safety will be assessed immediately post-operatively.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.	The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.	Safety will be assessed at the two-week follow-up visit.

Collaborators and Investigators

• Sponsor: Ascension South East Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Postoperative pain; Sacrocolpopexy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 1716019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No