Comparison of Quadratus Lumborum Block Types

Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Lumbar Disc Herniation; Opioid Use
• Intervention / Treatment: Drug: Multimodal Pharmacological Management; Drug: Ropivacaine injection Location 1; Drug: Ropivacaine injection Location 2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ryan M DeWolf, MS; Phone Number: 9783021857; Email: ryan.dewolf@umassmed.edu
• Study Contact Backup: Name: Ryan M DeWolf, ms; Phone Number: 7743032649; Email: ryan.dewolf@umassmemorial.org

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • UMass Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 Standard of Care; Group I will receive the standard of care multimodal pharmacological management.	Drug: Multimodal Pharmacological Management; standard of care multimodal pharmacological management
Experimental: 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.	Drug: Multimodal Pharmacological Management; standard of care multimodal pharmacological management; Drug: Ropivacaine injection Location 1; Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1; Other Names: Lidocaine
Experimental: Group 2 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.	Drug: Multimodal Pharmacological Management; standard of care multimodal pharmacological management; Drug: Ropivacaine injection Location 2; Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2; Other Names: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	0 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.	1 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.	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.	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.	18 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.	24 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.	30 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.	36 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.	42 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.	48ours
Discharge Opioid Use	The amount of left-over opioid pills at 2 weeks in the follow up visit.	2 weeks
Side Effects	The presence of any side effects reported.	Up to 1 week

Collaborators and Investigators

• Sponsor: Eman Nada
• Investigators: Principal Investigator: Eman Nada, MD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Nerve Block; Opioid Use; Lumbar Spine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: H00016236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers. However, results of the study will be shared through publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes