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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted supracervical or total laparoscopic hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy

• Age 18 years old or greater

• Fluency and literacy in English

• Capacity to provide consent

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Katelyn Donaldson, MD
katelyndonaldson@uabmc.edu
205-996-7372
Time Frame
Start Date: 2025-01-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 70
Treatments
Active_comparator: Quadratus Lumborum Block
The QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent (ropivacaine 60cc). Intraoperatively, patients will undergo subcutaneous injections of lidocaine (2cc per port site) at each port site. Preoperatively, patients will only receive acetaminophen and no preoperative narcotics or neuro-modulators will be administered. Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart.
Active_comparator: Enhanced Recovery After Surgery (ERAS) Protocol
The ERAS protocol is a multimodal approach to pain control while minimizing opioid medications. 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). Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov