Comparison of Quadratus Lumborum Block Types

NCT ID: NCT04588389

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-14

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.

Detailed Description

This study is a pilot study as part of planning for a larger randomized controlled trial. The study plans to enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. Group I will receive the standard of care multimodal pharmacological management. Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. Measurements of opioid use, pain, and side effects will be recorded for each patient.

Conditions

Pain; Opioid Use; Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Multimodal Pharmacological Management

Intervention Type: DRUG

standard of care multimodal pharmacological management

Group 2 Standard of Care + Quadratus Lumborum Block II

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

Group Type: EXPERIMENTAL

Ropivacaine injection Location 1

Intervention Type: DRUG

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

Multimodal Pharmacological Management

Intervention Type: DRUG

standard of care multimodal pharmacological management

Group 3 Standard of Care + Quadratus Lumborum Block III

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.

Group Type: EXPERIMENTAL

Ropivacaine injection Location 2

Intervention Type: DRUG

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

Multimodal Pharmacological Management

Intervention Type: DRUG

standard of care multimodal pharmacological management

Interventions

Ropivacaine injection Location 1

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

Intervention Type: DRUG

Ropivacaine injection Location 2

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

Intervention Type: DRUG

Multimodal Pharmacological Management

standard of care multimodal pharmacological management

Intervention Type: DRUG

Other Intervention Names

Lidocaine; Lidocaine; Standard of Care

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eman Nada, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Alexander Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

H00016236

Identifier Type: -

Identifier Source: org_study_id