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

Phase 4

Terminated

Conditions: Opioid Use
Pain, Postoperative

Interventions: Combination Product: Quadratus Lumborum Block
Procedure: Standard Medical Management

Registration Number: NCT03794882

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLB + Medical Management	Standard Medical Management	Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.
Standard Medical Management	Standard Medical Management	Subjects will receive Intervention: Procedure: Standard Medical Management as needed.
QLB + Medical Management	Quadratus Lumborum Block	Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.

Primary Outcome Measures

Name	Time	Method
Postoperative Day (POD) 1 Pain Score	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Pain Score at Rest	PACU, POD1, POD2, POD7	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.
Additional Analgesics in Milligrams Administered in the Operating Room	6 hours	This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.
Numbness Distribution in PACU	12 hours	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.
Total Antiemetic Consumption on POD 0 and in PACU	12 hours	Total consumption of antiemetics on POD 0 and in PACU.
Additional Analgesics in Milliliters Administered in the Operating Room	6 hours	This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.
Pain Score With Activity	PACU, POD1, POD2, POD7	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.
Postoperative Time to Discharge	72 hours	Total postoperative time until discharge.
Number of Participants With Presence of Nausea Necessitating Treatment	POD1, POD2, POD7	Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7
Rating of Satisfaction With Perioperative Care	POD1, POD2, POD7	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.
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams	12 hours	Total consumption of Non-Opioid Analgesics in the PACU.
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)	PACU, POD1, POD2, POD7	Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
Location of Most Severe Pain	PACU, POD1, POD2, POD7	Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.
Time in PACU	48 hours	Duration of patients' time in PACU.
Number of Participants Who Report Nausea in PACU	12 hours	Patient will be questioned to assess if they have nausea in PACU.