Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06309693
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Not yet recruiting
Phase	N/A
Start date	May 2024
Completion date	October 2025

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