Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

NCT04858438 | Unknown

• 1 other identifier: 1716019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Sacrocolpopexy; Pneumoperitoneum; Postoperative pain

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Standard Insufflation Group

ACTIVE COMPARATOR

Patients will receive standard insufflation during surgery (15 mm Hg).

Procedure: Insufflation during surgery

Low Insufflation Group

EXPERIMENTAL

Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).

Procedure: Insufflation during surgery

Interventions

Insufflation during surgery PROCEDURE

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

Low Insufflation Group; Standard Insufflation Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: This procedure only applies to women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing other procedures
• Patients who do not consent to participate.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

Related Publications (1)

• Rustia GM, Baracy MG Jr, Khair E, Hagglund KH, Aslam MF. Pain With Differing Insufflation Pressures During Robotic Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7.

  PMID: 37348093 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pneumoperitoneum; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gabriella Rustia, MD

CONTACT

313-343-6708; gabriella.rustia@ascension.org

Muhammad F Aslam, MD

CONTACT

313-343-3494; muhammad.aslam@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: April 2, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 31, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)