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

NCT ID: NCT03794882

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2020-03-12

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.

Conditions

Pain, Postoperative; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

QLB + Medical Management

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

Group Type: EXPERIMENTAL

Quadratus Lumborum Block

Intervention Type: COMBINATION_PRODUCT

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.

Standard Medical Management

Intervention Type: PROCEDURE

Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone

Standard Medical Management

Subjects will receive Intervention: Procedure: Standard Medical Management as needed.

Group Type: ACTIVE_COMPARATOR

Standard Medical Management

Intervention Type: PROCEDURE

Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone

Interventions

Quadratus Lumborum Block

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.

Intervention Type: COMBINATION_PRODUCT

Standard Medical Management

Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone

Intervention Type: PROCEDURE

Other Intervention Names

QLB

Eligibility Criteria

Inclusion Criteria

1. The subject is scheduled for elective laparoscopic ventral hernia repair;

2. The subject is ≥ 18 years and ≤ 80 years;

3. The patient agrees to receive a quadratus lumborum block

4. American Society of Anesthesiologists class 1-3.

Exclusion Criteria

1. Subject is < 18 years of age or >80 years of age;

2. Subject is non-English speaking;

3. Subject is known or believed to be pregnant;

4. Subject is a prisoner;

5. Subject has impaired decision-making capacity per discretion of the Investigator;

6. Significant renal, cardiac or hepatic disease per discretion of the investigator;

7. American Society of Anesthesiologists class 4-5;

8. Known hypersensitivity and/or allergies to local anesthetics;

9. Chronic opioid use (daily or almost daily use of opioids for > 3 months at any point in their lives).

10. Repair of a recurrent ventral hernia

11. Repair of multiple ventral hernias

12. Unobtainable sonographic views

13. Lacking health insurance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Bevil, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A530900

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/ANESTHESIOLOGY/ANESTHESIO

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/26/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0793

Identifier Type: -

Identifier Source: org_study_id