Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair (VHR)

April 29, 2025 updated by: University of Tennessee Graduate School of Medicine

Quadratus Lumborum Blocks for Pain Control Following Open Ventral Hernia Repair: A Double Blinded Randomized Control Trial

The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair.

Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.

The following information will be collected from you or your medical record:

  1. Pain medications given to you during surgery.
  2. Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
  3. Pain levels during the first 24 hours after surgery.
  4. Your total hospital length of stay after surgery.
  5. Any complications that you may have experienced after surgery.
  6. Demographic information, medical history as well as details about your hernia repair surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Quadratus Lumborum (QL) blocks have provided analgesia for abdominal surgery. These blocks involve ultrasound-guided local anesthetic injection deep into the anterior fascia of the quadratus lumborum into the thoracolumbar fascia, resulting in widespread abdominal and pelvic pain control. QL blocks extend that coverage from T4 to L1 in the paravertebral space. At this local institution, QL blocks have demonstrated the ability to provide complete sensory analgesia for most patients from T9-L1 up to an estimated 17 hours after surgery. Therefore the goal of this study is to evaluate the effectiveness of QL block in this patient population.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • The University of Tennessee Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jason M Buehler, MD

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. >18 years of age
  2. Able to read and understand study procedures
  3. Willing to participate and sign an informed consent form
  4. Open approaches to ventral hernia repair
  5. Clean (CDC Class I), clean-contaminated (CDC Class II)
  6. Elective surgery
  7. Mesh placed in the retromuscular position

Exclusion Criteria:

  1. Dirty-Infected cases (CDC Class IV): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
  2. Patient has a contraindication to receiving the drug and/or procedure: allergy/sensitivity to the drug, coagulopathy, abdominal wall infection at the drug administration site, systemic infection, anatomical distortion, neuropathy
  3. Emergent procedure
  4. Mesh not placed

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
The control (placebo comparator) group will undergo the same QL block procedure as the intervention arm, except saline (placebo) will be injected.
Procedure: Placebo
The placebo control group will receive the same quadratus lumborum (QL) block procedure as the intervention group, with the only difference being the injection of 60 mL of saline instead of local anesthetic. The anesthesiology team will administer 30 mL on each side of the abdominal wall, with one injection site per flank. The patient will be positioned in the left and right lateral decubitus positions, and the ultrasound probe will be placed above the iliac crest at the mid-axillary line to identify the "shamrock sign." The needle will be inserted through the QL muscle to the thoracolumbar fascia layer, between the QL and psoas muscle. After negative aspiration for blood, saline will be injected, allowing spread between the QL and psoas muscle on each side.
Experimental: Quadratus Lumborum Block
The Quadratus Lumborum block will be randomly administered to half of the study patients.
Procedure: Quadratus Lumborum (QL) Block
The intervention arm will receive bilateral quadratus lumborum blocks in the preoperative holding area prior to surgery. The syringe will contain a total of 60 mL of 0.25% Ropivacaine with 4 mg of Decadron. The anesthesiology pain team provider will administer 30 mL on the left side and 30 mL on the right side of the abdominal wall. The patient will receive one injection site per flank. During the procedure, the patient is placed in the left and then right lateral decubitus position and the ultrasound probe is placed above the iliac crest at the mid axillary line. The pain team provider will move the probe posteriorly to identify the "shamrock sign." Under ultrasound guidance, a needle is inserted in an in- plane approach through the quadratus lumborum (QL) muscle until reaching the middle of the thoracolumbar fascia layer between QL and psoas muscle. After negative aspiration for blood, injection will allow the spread of local anesthetic between the QL and psoas muscle on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Opioid Utilization
Time Frame: From the time of treatment until 24 hours after surgery
Quantity of Post-Operative Opioid Consumption as Measured by Morphine Milliequivalents for 24 Hours After Surgery
From the time of treatment until 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating Pain Score
Time Frame: From the time of treatment through hospitalization completion, an average of 4 days.

Patient-reported pain will be recorded by the nursing staff at a minimum once per day, every day from the time of surgery until the patient is discharged from the hospital, an average of 4 days.

Patient-reported pain will be scored on the validated Numeric Rating Scale (NRS), where patients are asked to choose a number between 0 and 10 that best describes their level of pain with "0" meaning "no pain" (better outcome) and "10" meaning "worst pain imaginable" (worse outcome).
From the time of treatment through hospitalization completion, an average of 4 days.

Collaborators and Investigators

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

Sponsor

University of Tennessee Graduate School of Medicine

Investigators

  • Principal Investigator: Kaela E Blake, MD, The University of Tennessee Graduate School of Medicine

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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

January 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5342

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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