Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Insufflation during surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacrocolpopexy, Pneumoperitoneum, Postoperative pain