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Comparison of Quadratus Lumborum Block Types

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04588389
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Eman Nada
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eman Nada, MD
Principal Investigator Affiliation University of Massachusetts, Worcester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pain, Opioid Use, Lumbar Disc Herniation
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Group 1 Standard of Care

Group I will receive the 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.

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.

Interventions

Drug: - Ropivacaine injection Location 1

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

Drug: - Ropivacaine injection Location 2

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

Drug: - Multimodal Pharmacological Management

standard of care multimodal pharmacological management

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UMASS Memorial Medical Center, Worcester, Massachusetts

Status

Recruiting

Address

UMASS Memorial Medical Center

Worcester, Massachusetts, 01605

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