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

University of Tennessee Graduate School of Medicine

Status: Not yet enrolling

Conditions: Pain Management; Hernia, Ventral

Treatments: Procedure: Quadratus Lumborum (QL) Block; Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06953635

5342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The control (placebo comparator) group will undergo the same QL block procedure as the intervention arm, except saline (placebo) will be injected.

Treatment:

Procedure: Placebo

Quadratus Lumborum Block

Experimental group

Description:

The Quadratus Lumborum block will be randomly administered to half of the study patients.

Treatment:

Procedure: Quadratus Lumborum (QL) Block