Ultrasound-guided L5 Dorsal Ramus Block (USGL5DR)

September 11, 2020 updated by: Roderick Finlayson, Montreal General Hospital

Ultrasound-guided L5 Dorsal Ramus Block: Description and Validation of a Novel Technique

This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients suffering from chronic low back pain. Because physical examination and medical imaging have limited value in determining the source of pain, diagnostic blocks play an important role in the management of this common condition. Blocks of the L5 dorsal ramus (DR) are used to diagnosed pain originating from the L5-S1 facet joint, which is one of the most commonly implicated levels in patients with low back pain. Fluoroscopic guidance, which uses x-rays, is currently the standard imaging modality used to perform this block. Recently, ultrasound guidance has seen increasing use because of its greater accessibility and lack of ionizing radiation. Although USG has been shown to provide a high level of accuracy at other levels, the greater anatomical complexity found at the L5-S1 has hindered the development of a satisfactory L5 DR block technique. In this study the investigators will use fluoroscopic control to examine the accuracy of a novel ultrasound-guided approach to this block.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1T2
        • Kelowna General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus

Description

Inclusion Criteria:

-Any consenting patient over 18 years of age with axial low back pain who requires a diagnostic L5 dorsal ramus block.

Exclusion Criteria:

  • Inability to consent
  • Iodine or lidocaine allergy,
  • Pregnancy,
  • Coagulopathy (as defined by an INR over 1.4, platelets under 100,000, or a documented bleeding disorder)
  • Inability to visualize lumbosacral anatomy during an ultrasound pre- scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary group
Ultrasound-Guided L5 Dorsal ramus block
Procedure: L5 Dorsal ramus block
Ultrasound-guided L5 dorsal ramus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block accuracy
Time Frame: Immediately post-injection
contrast distribution
Immediately post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance time
Time Frame: Perioperative
Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.
Perioperative
Number of needle passes
Time Frame: Procedure
Number of needle passes required to perform block
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal General Hospital

Collaborators

University of British Columbia
Kelowna General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2019

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-19-061-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Back

Clinical Trials on L5 Dorsal ramus block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe