Comparison of Quadratus Lumborum Block Types

University of Massachusetts, Worcester

Status and phase: Terminated; Phase 3

Conditions: Lumbar Disc Herniation; Opioid Use; Pain

Treatments: Drug: Ropivacaine injection Location 1; Drug: Multimodal Pharmacological Management; Drug: Ropivacaine injection Location 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04588389

H00016236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 3 patient groups

Group 1 Standard of Care

Active Comparator group

Description:

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

Treatment:

Drug: Multimodal Pharmacological Management

Group 2 Standard of Care + Quadratus Lumborum Block II

Experimental group

Description:

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

Treatment:

Drug: Multimodal Pharmacological Management

Drug: Ropivacaine injection Location 1

Group 3 Standard of Care + Quadratus Lumborum Block III

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine injection Location 2

Drug: Multimodal Pharmacological Management