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Completed

NCT Number: NCT06309693

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.

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Key information

Conditions

Pelvic Organ Prolapse Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Prolapse Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Lack fluency and literacy in English

Treatment and study plan

Quadratus Lumborum (QL) Block

Procedure

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.

Enhanced Recovery After Surgical (ERAS) Protocol

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Rates of overnight admission

    Time frame: Day of surgery

    Chart review will be performed to identify patients admitted postoperatively excluding planned admissions.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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