Comparison of Quadratus Lumborum Block Types

NCT04588389 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: H00016236
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain control after lumbar spinal fusion and if it reduces opioid consumption.

Conditions

Pain; Opioid Use; Lumbar Disc Herniation

Keywords

Lumbar Spine; Nerve Block; Opioid Use; Pain

Outcome Measures

Primary Outcomes (4)

• Opioid Consumption

  Dose of the opioids consumed

  12 hours

• Opioid Consumption

  Dose of the opioids consumed

  24 hours

• Opioid Consumption

  Dose of the opioids consumed

  36 hours

• Opioid Consumption

  Dose of the opioids consumed

  48 hours

Secondary Outcomes (12)

• Pain Scale

  0 Hours

• Pain Scale

  1 Hour

• Pain Scale

  6 Hours

• Pain Scale

  12 Hours

• Pain Scale

  18 Hours

Study Arms (3)

Group 1 Standard of Care

ACTIVE COMPARATOR

Group I will receive the standard of care multimodal pharmacological management.

Drug: Multimodal Pharmacological Management

Group 2 Standard of Care + Quadratus Lumborum Block II

EXPERIMENTAL

Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.

Drug: Ropivacaine injection Location 1; Drug: Multimodal Pharmacological Management

Group 3 Standard of Care + Quadratus Lumborum Block III

EXPERIMENTAL

Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.

Drug: Ropivacaine injection Location 2; Drug: Multimodal Pharmacological Management

Interventions

Ropivacaine injection Location 1 DRUG

Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1

Also known as: Lidocaine

Group 2 Standard of Care + Quadratus Lumborum Block II

Ropivacaine injection Location 2 DRUG

Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2

Also known as: Lidocaine

Group 3 Standard of Care + Quadratus Lumborum Block III

Multimodal Pharmacological Management DRUG

standard of care multimodal pharmacological management

Also known as: Standard of Care

Group 1 Standard of Care; Group 2 Standard of Care + Quadratus Lumborum Block II; Group 3 Standard of Care + Quadratus Lumborum Block III

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients undergoing lumbar spinal fusion surgery.
• Patients from 40-80 years.

You may not qualify if:

• Recent drug abuse
• History of illicit drug use
• Chronic pain patients not related to the back lesions.
• Opioid tolerant patients.
• Patients with any lower extremity weaknesses or deficits.
• Patients with American Society of Anesthesiologists (ASA) classification more than 3.
• Coagulopathy.
• Infection near or in the area of the block.
• Pregnant patients.
• Uncooperative patients who refuse care which directly effects research participation or clinical care.
• If the surgeon reports performing non-typical fusion.
• The presence of intraoperative complications like nerve injury or abnormal results of neuromonitoring and extensive dissection.
• Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.)
• Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Pain; Intervertebral Disc Displacement

Interventions

Lidocaine; Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Research project closed early due to departure of originating PI and despite departmental efforts, a new PI was not available to take over study. Study encountered coordination issues relative to Arm 1.

Results Point of Contact

• Title: Dr Alexander Chan for Eman Nada, MD
• Organization: UMass Chan Medical School

alexander.chan@umassmemorial.org

7743030338

Study Officials

• Eman Nada, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Alexander Chan, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: For the blinding purposes, the patients will be told that there are two possible sites at which they will receive the block. The sites will be either in the operating room before you wake up from anesthesia or in the post-anesthesia care unit (PACU). The patients on the medical management group will be told that they have received their block before recovering from anesthesia, the PACU nurse will be told the same as well to make him or her blinded as a pain assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will randomize 10 patients into one of three groups for a total of 30 patients. Each patient will be longitudinally followed until discharge.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)