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

NCT06709716 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: WRNMMC-2024-0448
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Postoperative Pain; Laparoscopic Hysterectomy; Nerve Block; Quadratus Lumborum Block

Keywords

postoperative pain; quadratus lumborum block; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (2)

• Intraoperative opioid use

  Total opioid dose, calculated in morphine equivalent dose, required during intraoperative anesthesia care

  From anesthesia induction to the time the patient leaves the operating room, this is considered the "in-room time". Anticipated to be between 2-6 hours. Will be assessed up to 12 hours.

• Immediate post-operative opioid use

  Total opioid dose, calculated in morphine equivalent dose, required after surgery prior to discharge from the hospital

  From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.

Secondary Outcomes (6)

• Opioid use after discharge

  From discharge from the hospital to the 4-6 week post-operative appointment.

• Pain scores during inpatient post-operative care

  From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.

• Time to PACU discharge

  From time of arrival in the PACU to time of transfer to the second phase of post-operative care. Anticipated to be about 1-3 hours post-operative. Will be assessed up to 12 hours after surgery if the patient remains in the PACU.

• Voiding dysfunction

  From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.

• Pain scores after discharge

  From discharge from the hospital to the 4-6 week post-operative appointment.

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Quadratus Lumborum Block (QLB); Drug: Local Anesthetic Solution

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

ACTIVE COMPARATOR

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.

Drug: Quadratus lumborum block; Drug: Local Anesthetic Solution

Interventions

Quadratus Lumborum Block (QLB) DRUG

Pre-operative quadratus lumborum block with liposomal bupivacaine

Also known as: liposomal bupivacaine

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

Quadratus lumborum block DRUG

Pre-operative quadratus lumborum block with saline

Also known as: saline

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

Local Anesthetic Solution DRUG

Intraoperative injection of 0.25% bupivacaine at each incision site

Also known as: bupivacaine

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• 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 Nov;15(11):783-790. doi: 10.1080/17581869.2025.2556648. Epub 2025 Sep 9.

  PMID: 40923200 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kathryn A Edmonds, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn A Edmonds, MD

CONTACT

301-319-8866; kathryn.a.edmonds2.mil@health.mil

Candice E Jones-Cox, MD

CONTACT

301-319-8866; candice.e.jones-cox.civ@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 29, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)