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

NCT03794882 | Terminated Phase 4 Results DMC FDA Drug

• 4 other identifiers: 2018-0793A530900SMPH/ANESTHESIOLOGY/ANESTHESIOProtocol Version 8/26/2019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Opioid Use

Keywords

Hernia, Ventral; Pain, Postoperative; Opioid Use; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Pain Score at Rest

  PACU, POD1, POD2, POD7

• Pain Score With Activity

  PACU, POD1, POD2, POD7

• Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)

  PACU, POD1, POD2, POD7

• Location of Most Severe Pain

  PACU, POD1, POD2, POD7

• Time in PACU

  48 hours

Study Arms (2)

QLB + Medical Management

EXPERIMENTAL

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

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

Standard Medical Management

ACTIVE COMPARATOR

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

Procedure: Standard Medical Management

Interventions

Quadratus Lumborum Block 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.

Also known as: QLB

QLB + Medical Management

Standard Medical Management PROCEDURE

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

QLB + Medical Management; Standard Medical Management

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Ventral; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Limitations and Caveats

This study was terminated early due to the combined effects of the COVID-19 pandemic and the switching of the primary location for the procedure from UW Hospital to East Madison Hospital.

Results Point of Contact

• Title: Dr Kristin Bevil
• Organization: University of Wisconsin-Madison

kbevil@wisc.edu

6082638100

Study Officials

• Kristin Bevil, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant is blinded to the treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 7, 2019
• Study Start: May 6, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)