Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee Graduate School of Medicine
Study ID
NCT06953635
Status
Not Yet Recruiting

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Conditions

  • Hernia, Ventral
  • Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quadratus Lumborum (QL) Block — PROCEDURE
    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.
  • Placebo — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Mar 2025
Primary completion
Jan 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: Quadratus Lumborum Block
    The Quadratus Lumborum block will be randomly administered to half of the study patients.

Primary Outcome Measure

Post-operative Opioid Utilization [ Time Frame: From the time of treatment until 24 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Tennessee Medical CenterKnoxvilleTennessee37920
Trey A Henderson, MD
[email protected]
865-305-7540
Elizabeth A LaFontaine, BS, MBSCR, CNC
[email protected]
865-305-9662
Jason M Buehler, MD (SUB_INVESTIGATOR)

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By research site
The University of Tennessee Medical Center· Knoxville, TN

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