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NCT Number: NCT04858438

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.

Why the study stopped: Joint venture occurred and PI did not continue study.
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Key information

Conditions

Pelvic Organ Prolapse Digestive System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Postoperative Complications Prolapse Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insufflation during surgery

Procedure

This is the amount of insufflation using during the surgical procedure.

Primary outcomes

  1. Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.

    Time frame: Pain will be assessed within 24 hours of the surgery. .

    Pain will be assessed during the 24-hour post-operative period.

  2. Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.

    Time frame: Pain will be assessed at the two-week post-operative follow-up visit.

    Pain will be assessed during the two-week post-operative period.

  3. Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

    Time frame: Safety will be assessed during the procedure.

    The safety of the lower insufflation pressure will be assessed during the procedure.

  4. Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

    Time frame: Safety will be assessed immediately post-operatively.

    The safety of the lower insufflation pressure will be assessed immediately post-operatively.

  5. Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2021
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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