NCT06309693

Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy

Effect of Quadratus Lumborum (QL) Block in Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery.

Detailed description

The purpose of this study is to compare patient reported postoperative pain scores in women undergoing QL block versus ERAS protocol alone prior to minimally invasive sacrocolpopexy. Secondary aims will explore other outcomes that impact patients' overall postoperative pain experience. Aim #1: To compare the median postoperative patient reported pain score in PACU between patients undergoing minimally invasive sacrocolpopexy, who are randomized to a preoperative QL block and the ERAS alone group. Aim #2: To compare the maximum postoperative patient reported pain score in PACU between patients undergoing minimally invasive sacrocolpopexy, who are randomized to a preoperative QL block and the ERAS alone group. Aim #3: To compare the total oral morphine equivalents (OME) in PACU between patients undergoing minimally invasive sacrocolpopexy, who are randomized to a preoperative QL block and the ERAS alone group. Aim #4: To compare the rates of postoperative nausea and vomiting (PONV between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy. Aim #5: To compare the rates of overnight admission between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy. Aim #6: To compare the total time in the PACU between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy. Aim #7: To compare the rates of initial active voiding trial failures between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy.

Conditions

• Pelvic Organ Prolapse
• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	Quadratus Lumborum (QL) Block	The standard of care QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent. Patients will subsequently be asked about their pain postoperatively and opioid medication administration will be quantified.
PROCEDURE	Enhanced Recovery After Surgical (ERAS) Protocol	Subjects randomized to the ERAS arm will undergo the standard ERAS protocol of early postoperative ambulation, no bowel preparation, and the use of multimodal pain medications including acetaminophen and non-steroid anti-inflammatory drugs (NSAIDs). Patients will subsequently be asked about their pain postoperatively and opioid medication administration will be quantified.

Timeline

• Start date: 2025-01-22
• Primary completion: 2025-12-31
• Completion: 2026-01-09
• First posted: 2024-03-13
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States