Single Port Insufflation RCT

NCT06990750 | Completed DMC

• 1 other identifier: IRB23-1711
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Score

Keywords

insufflation pressure; postoperative pain; surgeon visualization; robotic sacrocolpopexy; single port sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• Post anesthesia Care Unit Pain

  Immediate after surgery in the post anesthesia care unit (PACU), patients were asked to rate their pain using a 100 point numeric rating scale (0 \[no pain\] to 100 \[worst imaginable pain\]). The PACU nurse routine asked pain score with routine vitals. The median score was recorded.

  0 mins-4 hours after surgery

Secondary Outcomes (6)

• Post anesthesia care unit morphine milligram equivalents

  0 mins-4 hours

• Postoperative day one pain

  24 hours after surgery

• Postoperative day one morphine milligram equivalents

  24 hours after surgery

• Postoperative day 14 pain

  14 days after surgery

• Postoperative day 14 morphine milligram equivalents

  14 days after surgery

Study Arms (2)

Standard pressure

ACTIVE COMPARATOR

Insufflation pressure set to 15 mmHg (standard pressure).

Procedure: 15 mmHg

Experimental Pressure

EXPERIMENTAL

Insufflation pressure set to 12 mm Hg (experimental pressure)

Procedure: 12 mmHg

Interventions

15 mmHg PROCEDURE

Insufflation pressure was set to 15 mm Hg at the time of single port robotic sacrocolpopexy.

Also known as: Standard insufflation pressure

Standard pressure

12 mmHg PROCEDURE

Insufflation pressure was set to 12 mm Hg at the time of single port robotic sacrocolpopexy.

Also known as: Experimental insufflation pressure

Experimental Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women scheduled for single port robotic sacrocolpopexy for uterovaginal or vaginal vault prolapse

You may not qualify if:

• Non-english speaking
• Inability to complete study questionnaires

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Ashmore S, Burgard I, Russo D, Kenton K, Lewicky-Gaupp C, Collins SA, Mueller MG. Insufflation Pressure and Pain After Single-Port Robotic Sacrocolpopexy. Urogynecology (Phila). 2026 Apr 1;32(4):430-437. doi: 10.1097/SPV.0000000000001814.

  PMID: 41854467 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Margaret G Mueller, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)