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Impact of Preoperative Quadratus Lumborum Block on Postoperative Opioid Consumption After Laparoscopic Hysterectomy

NCT ID: NCT06709716

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-02-28

Brief Summary

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The goal of this clinical trial is to learn if preoperative nerve block (quadratus lumborum \[QL\] block) works to improve pain control during and after laparoscopic hysterectomy. The main questions it aims to answer are:

Does QL block decrease the amount of narcotic medication needed during surgery? Does QL block decrease the amount of narcotic medication needed after surgery?

Researchers will compare QL block to local injection of a numbing medication at each incision site (the current standard practice) to see if QL block works to decrease surgical pain.

Participants will be randomly assigned to receive one of the two following interventions:

1. QL block before surgery with a long-acting numbing medicine (liposomal bupivacaine) and then injection of placebo (saline) at each incision site in the operating room.
2. QL block before surgery with placebo (saline) and then injection of local numbing medicine (bupivacaine) at each incision site in the operating room.

Participants will also:

* Visit the clinic/hospital for a pre-operative appointment, the surgical procedure, and a 4-6 week post-operative appointment (all standard visits even if not participating in research)
* Complete a questionnaire electronically, or by phone, that takes \<10 minutes at the pre-operative appointment and on postoperative days 1, 3, 5, 14, and 4-6 weeks.

Detailed Description

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Context: (Background) Given the opioid epidemic, gynecologic enhanced recovery after surgery (ERAS) pathways have been developed to reduce post-operative narcotic use through multimodal pain regimens and pre-surgical anesthetic adjuncts. While local anesthetic injection at trocar incision sites has long been accepted as a standard practice to decrease postoperative pain in laparoscopic surgery, including hysterectomy, regional nerve blockades are emerging as a promising adjunct technique for management of perioperative pain. At this time, the data evaluating the effect of regional nerve blocks on postoperative pain after laparoscopic hysterectomy are limited, thus the investigators designed the following study.

Objectives: (primary and secondary objectives) To determine the impact of preoperative quadratus lumborum (QL) block on postoperative pain following laparoscopic hysterectomy. The primary outcomes will be intraoperative and immediate post-operative opioid use, measured in morphine equivalent dose (MED). Secondary outcomes will include pain scores, functional impact of pain, perception of pain and recovery, voiding dysfunction, time to discharge, nausea/vomiting, emergency room visits, readmission, and reoperation rates.

Study Design:

This study is designed as a prospective, double-blinded, randomized controlled trial comparing opioid use in women undergoing laparoscopic hysterectomy who receive a preoperative QL block to local injection of bupivacaine (common local anesthestic).

Setting/Participants:

The study will take place at a single academic medical center that is a referral center within the military health system. Eligible patients will include adult women undergoing laparoscopic hysterectomy, including robot-assisted, that are not pain management clinic patients and don't use opioids preoperatively. Patients who have contraindications to the study protocol will be ineligible. A total of 76 patients will be enrolled with 38 in each arm.

Study Interventions and Measures:

Study arm patients will receive a preoperative bilateral QL block with an admixture of liposomal bupivacaine and 0.25% bupivacaine then an intraoperative placebo injection at each incision site with 0.9% saline. Control arm patients will receive a preoperative bilateral placebo QL block with 0.9% saline then an intraoperative injection of 0.25% bupivacaine at each incision site. Pre, intra, and postoperative care will be standardized for all study patients using the Gynecologic ERAS protocol and standard hospital perioperative procedures/protocols.

Opioid use will be measured in morphine equivalent doses (MEDs) at the intraoperative and immediate postoperative (prior to discharge) timepoints, as well as, at postoperative days 1, 3, 5, 14, and 4-6 weeks. Pain scores and impact of pain on functional status will be assessed using the DVPRS and Quality of Recovery-15 survey at these timepoints.

Conditions

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Postoperative Pain Laparoscopic Hysterectomy Nerve Block Quadratus Lumborum Block

Keywords

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postoperative pain quadratus lumborum block laparoscopic hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Blinded parties = subject, surgical team, intraoperative anesthesia team, postoperative anesthesia team, study investigators Unblinded parties = preoperative anesthesia team (providers that perform the quadratus lumborum block)

Study Groups

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Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo

Subjects will receive a pre-operative quadratus lumborum nerve block with liposomal bupivacaine and then an intra-operative placebo injection at each incision site with saline.

Group Type EXPERIMENTAL

Quadratus Lumborum Block (QLB)

Intervention Type DRUG

Pre-operative quadratus lumborum block with liposomal bupivacaine

Local Anesthetic Solution

Intervention Type DRUG

Intraoperative injection of saline at each incision site.

Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine

Subjects will undergo a sham pre-operative quadratus lumborum block procedure with saline and then an intra-operative injection of local anesthetic (0.25% bupivacaine) at each incision site.

Group Type ACTIVE_COMPARATOR

Quadratus lumborum block

Intervention Type DRUG

Pre-operative quadratus lumborum block with saline

Local Anesthetic Solution

Intervention Type DRUG

Intraoperative injection of 0.25% bupivacaine at each incision site

Interventions

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Quadratus Lumborum Block (QLB)

Pre-operative quadratus lumborum block with liposomal bupivacaine

Intervention Type DRUG

Quadratus lumborum block

Pre-operative quadratus lumborum block with saline

Intervention Type DRUG

Local Anesthetic Solution

Intraoperative injection of 0.25% bupivacaine at each incision site

Intervention Type DRUG

Local Anesthetic Solution

Intraoperative injection of saline at each incision site.

Intervention Type DRUG

Other Intervention Names

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liposomal bupivacaine saline bupivacaine Saline

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* scheduled to undergo laparoscopic hysterectomy
* able to speak and understand English
* DEERs eligible (eligible for healthcare within military heath system)
* Owning a phone that can receive text messages or having internet access to complete questionnaires

Exclusion Criteria

* pre-operative opioid use
* pre-operative pain management clinic patient
* planned concomitant prolapse or incontinence procedure
* planned concomitant non-gynecologic abdominal procedure (i.e. hernia repair)
* inability to receive liposomal or non-liposomal bupivacaine
* inability to receive non-steroidal anti-inflammatory drugs (NSAIDs)
* inability to receive acetaminophen
* inability to receive oxycodone
* QL block not able to be performed bilaterally
* planned or performed mini-laparotomy (incision greater than 2cm)
* case converted to laparotomy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Walter Reed National Military Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn A Edmonds, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

Central Contacts

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Kathryn A Edmonds, MD

Role: CONTACT

Phone: 301-319-8866

Email: [email protected]

Candice E Jones-Cox, MD

Role: CONTACT

Phone: 301-319-8866

Email: [email protected]

Facility Contacts

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Kathryn A Edmonds, MD

Role: primary

Candice E Jones-Cox, MD

Role: backup

Kathryn A Edmonds, MD

Role: backup

References

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Edmonds K, Hunkler K, Creedon C, Drayer S, Endicott S, Eliasen K, Jones-Cox C. Impact of preoperative quadratus lumborum block on postoperative opioid consumption after laparoscopic hysterectomy: a double-blind randomized controlled trial. Pain Manag. 2025 Sep 9:1-8. doi: 10.1080/17581869.2025.2556648. Online ahead of print.

Reference Type DERIVED
PMID: 40923200 (View on PubMed)

Other Identifiers

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WRNMMC-2024-0448

Identifier Type: -

Identifier Source: org_study_id