Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quadratus Lumborum (QL) Block, Placebo.
- Who it may be relevant to
- Registry conditions: Hernia, Ventral, Pain Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quadratus Lumborum Blocks for Pain Control Following Open Ventral Hernia Repair: A Double Blinded Randomized Control Trial
Overview
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.
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.
Interventions
- 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 ultr - 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 ide
Primary outcome measures
- Post-operative Opioid Utilization [Time frame: From the time of treatment until 24 hours after surgery]
Secondary outcome measures (1)
- Numerical rating Pain Score [Time frame: From the time of treatment through hospitalization completion, an average of 4 days.]
Eligibility criteria
Inclusion criteria
- >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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Tennessee Medical Center — Knoxville
Publications
- 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
- 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
- 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- PMID 20685078
- 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)005 PMID 35717988
- 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
Identifiers
NCT: NCT06953635 · 5342