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Clinical Trials/NCT04588389
NCT04588389
Terminated
Phase 3

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

University of Massachusetts, Worcester1 site in 1 country9 target enrollmentDecember 1, 2020

Overview

Phase
Phase 3
Intervention
Multimodal Pharmacological Management
Conditions
Pain
Sponsor
University of Massachusetts, Worcester
Enrollment
9
Locations
1
Primary Endpoint
Opioid Consumption
Status
Terminated
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
May 14, 2021
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Sponsor

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
  • 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.

Arms & Interventions

Group 1 Standard of Care

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

Intervention: 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.

Intervention: Ropivacaine injection Location 1

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.

Intervention: 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.

Intervention: Ropivacaine injection Location 2

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.

Intervention: Multimodal Pharmacological Management

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: 48 hours

Dose of the opioids consumed

Secondary Outcomes

  • Pain Scale(48 hours)
  • Discharge Opioid Use(2 weeks)
  • Number of Participants Experiencing Side Effects(Up to 1 week)

Study Sites (1)

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