Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy

January 9, 2026 updated by: Katelyn Donaldson, MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted supracervical or total laparoscopic hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy
  2. Age 18 years old or greater
  3. Fluency and literacy in English
  4. Capacity to provide consent

Exclusion Criteria:

1. Lack fluency and literacy in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU)
Time Frame: Immediate postoperative period while patient is in the PACU
Patients will be asked to rate their pain according to the numeric pain rating scale (0-10) by the nursing staff postoperatively at regular intervals in the PACU and the median score will be calculated.
Immediate postoperative period while patient is in the PACU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum postoperative patient reported pain score in PACU
Time Frame: Immediate postoperative period while patient is in the PACU
Patients will be asked to rate their pain according to the numeric pain rating scale (0-10) by the nursing staff postoperatively at regular intervals in the PACU and the maximum score will be identified.
Immediate postoperative period while patient is in the PACU
Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit
Time Frame: Immediate postoperative period while patient is in the PACU
The total quantities of opioid pain medications will be identified on patient chart review and calculated into total OME.
Immediate postoperative period while patient is in the PACU
Rates of postoperative nausea and vomiting (PONV) in PACU
Time Frame: Immediate postoperative period while patient is in PACU
Rates of PONV will be determine by administration of anti-emetic medication in PACU or documentation of PONV in notes.
Immediate postoperative period while patient is in PACU
Rates of overnight admission
Time Frame: Day of surgery
Chart review will be performed to identify patients admitted postoperatively excluding planned admissions.
Day of surgery
Total time spent in PACU
Time Frame: Immediate postoperative period while patient is in the PACU
The total time spent in PACU will be calculated based on chart review.
Immediate postoperative period while patient is in the PACU
Rates of initial active voiding trial failures
Time Frame: Immediate postoperative period while patient is in the post-anesthesia recovery unit
The rates of initial voiding trial failures will be calculated based on chart review.
Immediate postoperative period while patient is in the post-anesthesia recovery unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 9, 2026

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300011310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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