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Nerve Block

Quadratus Lumborum Block for Postoperative Pain

Phase 4

Waitlist Available

Led By Kathryn A Edmonds, MD

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Scheduled to undergo laparoscopic hysterectomy

Must not have

Inability to receive oxycodone

Case converted to laparotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to see if a nerve block called quadratus lumborum (QL) block can help with pain control during and after laparoscopic hysterectomy. Researchers want to know if using Q

Who is the study for?

This trial is for individuals scheduled for laparoscopic hysterectomy who are interested in better pain control. Participants must attend standard pre-operative and post-operative appointments, as well as complete short questionnaires on their pain levels at specified times after surgery.

What is being tested?

The study tests if a QL block with liposomal bupivacaine before surgery reduces the need for narcotic medication during and after the procedure compared to just local numbing at incision sites. Patients will be randomly assigned to receive either the QL block or placebo plus local anesthetic.

What are the potential side effects?

Potential side effects may include discomfort or bruising at the injection site, allergic reactions to anesthetics, nerve damage, infection risk from injections, and typical surgical risks like bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a laparoscopic hysterectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take oxycodone.

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My surgery was changed to an open procedure.

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I cannot have a QL block done on both sides of my body.

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I have used opioids before surgery.

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I am scheduled for a non-gynecologic abdominal procedure, like hernia repair.

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I cannot take NSAIDs.

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I am scheduled for surgery to fix prolapse or incontinence.

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I cannot receive certain pain medications.

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I am scheduled for or have had a surgery with an incision larger than 2cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immediate post-operative opioid use

Intraoperative opioid use

Secondary study objectives

Opioid use after discharge

Pain scores after discharge

Pain scores during inpatient post-operative care

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placeboExperimental Treatment2 Interventions

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 II: Preoperative QL block with placebo, intra-operative incisional injection with bupivacaineActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Local Anesthetic Solution

2019

Completed Phase 3

~180

Quadratus Lumborum Block (QLB)

2022

Completed Phase 4

~150