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Ultrasound-guided L5 Dorsal Ramus Block (USGL5DR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03805906
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
University of British Columbia
Kelowna General Hospital
Information provided by (Responsible Party):
Roderick Finlayson, Montreal General Hospital

Study Description
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Brief Summary:
This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.

Condition or disease Intervention/treatment
Pain, Back Procedure: L5 Dorsal ramus block

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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound-guided L5 Dorsal Ramus Block: Description and Validation of a Novel Technique
Actual Study Start Date : January 12, 2019
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary group
Ultrasound-Guided L5 Dorsal ramus block
 Procedure: L5 Dorsal ramus block
Ultrasound-guided L5 dorsal ramus block


Outcome Measures
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Primary Outcome Measures :
  1. Block accuracy [ Time Frame: Immediately post-injection ]
    contrast distribution


Secondary Outcome Measures :
  1. 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.

  2. Number of needle passes [ Time Frame: Procedure ]
    Number of needle passes required to perform block


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805906


Locations
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Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y 1T2
Sponsors and Collaborators
Montreal General Hospital
University of British Columbia
Kelowna General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Roderick Finlayson, Professor, Montreal General Hospital
ClinicalTrials.gov Identifier: NCT03805906    
Other Study ID Numbers: 2018-19-061-H
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations