Clinical trial NCT04858438: Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
Official title: Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Sacrocolpopexy
Pneumoperitoneum
Postoperative pain
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
timeFrame: Pain will be assessed within 24 hours of the surgery. .
measure: Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
timeFrame: Pain will be assessed at the two-week post-operative follow-up visit.
measure: Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
timeFrame: Safety will be assessed during the procedure.
measure: Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
timeFrame: Safety will be assessed immediately post-operatively.
measure: Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
timeFrame: Safety will be assessed at the two-week follow-up visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
Study officials:
References: