Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair

NCT06953635 | Not Yet Recruiting

• 1 other identifier: 5342
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hernia, Ventral; Pain Management

Keywords

Regional Anesthesia; Postoperative Pain; Ventral Hernia Repair

Outcome Measures

Primary Outcomes (1)

• Post-operative Opioid Utilization

  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 Outcomes (1)

• Numerical rating Pain Score

  From the time of treatment through hospitalization completion, an average of 4 days.

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Procedure: Placebo

Quadratus Lumborum Block

EXPERIMENTAL

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

Procedure: Quadratus Lumborum (QL) Block

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.

Quadratus Lumborum Block

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.

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Dirty-Infected cases (CDC Class IV): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
• 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
• Emergent procedure
• Mesh not placed

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Related Publications (5)

• Roy A, Bhoi D, Chhabra A, Mohan VK, Darlong V, Prasad G. Quadratus lumborum block vs. transversus abdominis plane block in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia in adults: A randomised controlled trial. Indian J Anaesth. 2023 Feb;67(2):207-215. doi: 10.4103/ija.ija_304_22. Epub 2023 Feb 16.

  PMID: 37091451 RESULT

• Liu X, Song T, Chen X, Zhang J, Shan C, Chang L, Xu H. Quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing abdominal surgeries: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Mar 2;20(1):53. doi: 10.1186/s12871-020-00967-2.

  PMID: 32122319 RESULT

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 RESULT

• Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.

  PMID: 35717988 RESULT

• Schlosser KA, Renshaw SM, Tamer RM, Strassels SA, Poulose BK. Ventral hernia repair: an increasing burden affecting abdominal core health. Hernia. 2023 Apr;27(2):415-421. doi: 10.1007/s10029-022-02707-6. Epub 2022 Dec 26.

  PMID: 36571666 RESULT

MeSH Terms

Conditions

Hernia, Ventral; Agnosia; Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Kaela E Blake, MD

  The University of Tennessee Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaela E Blake, MD

CONTACT

865-305-9620; kblake@utmck.edu

Trey A Henderson, MSc

CONTACT

865-305-7540; thenderson@utmck.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design This is a prospective, double-blinded, randomized, placebo-controlled clinical trial comparing QL blocks to placebo for pain control for patients undergoing open VHR.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: May 1, 2025
• Study Start: June 1, 2025
• Primary Completion: January 28, 2026
• Study Completion: February 28, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)