Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair

Study Overview
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Brief Summary
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Ventral hernia repair may be associated with significant postoperative pain. Pain is typically managed with intravenous (IV) and oral medications that come with their own risks, such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can improve pain scores, decrease the need for IV and oral pain medications, and/or speed the patients' return to normal activity.

Detailed Description
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Current trends in perioperative pain management stress the importance of multimodal analgesia in an effort to reduce the dependence on opioid pain medications. Adverse effects of opioids include sedation, respiratory depression, nausea, vomiting, constipation, itching, and, most importantly, the potential for tolerance and abuse. Multimodal analgesia attempts to utilize multiple techniques, including medications and nerve block procedures, to improve postoperative analgesia. Improved postoperative pain control can enable an earlier return to normal activities for patients, not only improving patient satisfaction, but also reducing postoperative morbidity and adverse effects of opioids. Approximately 350,000 to 500,000 ventral hernia repairs are performed each year in the United States. Surgeries completed laparoscopically are typically performed on an outpatient basis, allowing patients to return home the same day of surgery and treat their pain independently with prescribed pain medications. Utilization of a regional anesthesia technique may allow prolonged numbing of the nerves postoperatively and decrease the reliance on oral pain medications. Transversus abdominis plane (TAP) blocks have been shown to decrease pain scores and opioid consumption following ventral hernia repair. Quadratus lumborum (QL) blocks are newer iterations of the TAP block. There are currently three types of the QL block, all targeting the thoracolumbar fascia surrounding the quadratus lumborum muscle. Injection within this fascial plane may allow local anesthetic spread into the paravertebral space, possibly explaining why QL blocks have been mapped from the T7 to T12/L1 dermatomes, covering the entire abdomen. Conversely, TAP blocks have been mapped from the T10 to T12/L1 dermatomes, only covering the abdomen below the umbilicus. In the first, the Quadratus lumborum 1 block (QL1), the local anesthetic is injected within the fascial plane lateral to the QL muscle. In the second, the Quadratus lumborum 2 block (QL2), the needle trajectory is more superficial, and the local anesthetic is injected along the posterior border of the QL muscle. The third iteration, the Quadratus lumborum 3 block (QL3), involves a deeper, transmuscular approach with injection along the anterior border of the QL muscle. Our study would utilize the QL2 approach as the dermatomal distribution of the QL1 and QL2 blocks appear to be more widespread than the QL3 block, and the QL2 block may be a safer approach due to the more superficial angle of the needle 3. Additionally, the QL block has been shown to have a longer duration of analgesia when directly compared to the TAP block. A study of pediatric lower abdominal surgery revealed improved pain scores and parent satisfaction with care in the QL group compared to TAP block. This improvement persisted to the 24 hour mark. In a study of postoperative pain following cesarean delivery, pain scores were improved and opioid consumption decreased with the QL block compared to the TAP block. The differences were not significant at the 1 and 6 hour marks, but were significant at the 12, 24 and 48 hour marks, highlighting the analgesic duration of the QL block 8. This study aims to evaluate the efficacy of the QL block using the QL2 approach on recovery profile after laparoscopic ventral hernia repair, a commonly performed surgery, as well as contribute to the understanding of the block and its distribution of anesthesia.

Official Title
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Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair

Conditions
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Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Combination Product: Quadratus Lumborum Block
* Procedure: Standard Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is scheduled for elective laparoscopic ventral hernia repair; The subject is ≥ 18 years and ≤ 80 years; The patient agrees to receive a quadratus lumborum block American Society of Anesthesiologists class 1-3. Exclusion Criteria: Subject is < 18 years of age or >80 years of age; Subject is non-English speaking; Subject is known or believed to be pregnant; Subject is a prisoner; Subject has impaired decision-making capacity per discretion of the Investigator; Significant renal, cardiac or hepatic disease per discretion of the investigator; American Society of Anesthesiologists class 4-5; Known hypersensitivity and/or allergies to local anesthetics; Chronic opioid use (daily or almost daily use of opioids for > 3 months at any point in their lives). Repair of a recurrent ventral hernia Repair of multiple ventral hernias Unobtainable sonographic views Lacking health insurance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLB + Medical Management<br>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. | Combination Product: Quadratus Lumborum Block<br>* 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line.<br>* Other names: QLB;Procedure: Standard Medical Management<br>* Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone<br>|
| Active Comparator: Standard Medical Management<br>Subjects will receive Intervention: Procedure: Standard Medical Management as needed. | Procedure: Standard Medical Management<br>* Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Day (POD) 1 Pain Score | Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at Rest | Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | PACU, POD1, POD2, POD7 | 
| Pain Score With Activity | Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | PACU, POD1, POD2, POD7 | 
| Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7. | PACU, POD1, POD2, POD7 | 
| Location of Most Severe Pain | Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7. | PACU, POD1, POD2, POD7 | 
| Time in PACU | Duration of patients' time in PACU. | 48 hours | 
| Postoperative Time to Discharge | Total postoperative time until discharge. | 72 hours | 
| Numbness Distribution in PACU | For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point. | 12 hours | 
| Number of Participants Who Report Nausea in PACU | Patient will be questioned to assess if they have nausea in PACU. | 12 hours | 
| Total Antiemetic Consumption on POD 0 and in PACU | Total consumption of antiemetics on POD 0 and in PACU. | 12 hours | 
| Number of Participants With Presence of Nausea Necessitating Treatment | Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7 | POD1, POD2, POD7 | 
| Rating of Satisfaction With Perioperative Care | Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction. | POD1, POD2, POD7 | 
| Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | Total consumption of Non-Opioid Analgesics in the PACU. | 12 hours | 
| Additional Analgesics in Milliliters Administered in the Operating Room | This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room. | 6 hours | 
| Additional Analgesics in Milligrams Administered in the Operating Room | This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, Ventral, Pain, Postoperative, Opioid Use, Pain