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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805906
Other study ID # 2018-19-061-H
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2019
Est. completion date April 30, 2019

Study information

Verified date September 2020
Source Montreal General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
L5 Dorsal ramus block
Ultrasound-guided L5 dorsal ramus block

Locations

Country Name City State
Canada Kelowna General Hospital Kelowna British Columbia

Sponsors (3)

Lead Sponsor Collaborator
Montreal General Hospital Kelowna General Hospital, University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Block accuracy contrast distribution Immediately post-injection
Secondary Performance time Performance time as defined by the time the first image is acquired until the time the contrast injection is completed. Perioperative
Secondary Number of needle passes Number of needle passes required to perform block Procedure
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