Comparison of Quadratus Lumborum Block Types

Phase 3TerminatedNCT04588389

University of Massachusetts, Worcester9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain Opioid Use Lumbar Disc Herniation

Interventions

Ropivacaine injection Location 1DRUG

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

Ropivacaine injection Location 2DRUG

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

Multimodal Pharmacological ManagementDRUG

standard of care multimodal pharmacological management

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Opioid Consumption

Dose of the opioids consumed

Time frame: 12 hours

Opioid Consumption

Dose of the opioids consumed

Time frame: 24 hours

Opioid Consumption

Dose of the opioids consumed

Time frame: 36 hours

Opioid Consumption

Dose of the opioids consumed

Time frame: 48 hours

Secondary Outcomes

Pain Scale

Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.

Time frame: 0 Hours

Pain Scale

Numerical Pain Scale Rating of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.

Time frame: 1 Hour

Pain Scale

Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.

Time frame: 6 Hours

Pain Scale

Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.

Time frame: 12 Hours

Pain Scale

Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.

Data from ClinicalTrials.gov

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