USGL5DR: Ultrasound-guided L5 Dorsal Ramus Block

Sponsor

Montreal General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03805906

Collaborator

University of British Columbia (Other), Kelowna General Hospital (Other)

100

Enrollment

Location

3.5

Actual Duration (Months)

28.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

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 :

Jan 12, 2019

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Primary group

Ultrasound-Guided L5 Dorsal ramus block

Procedure: L5 Dorsal ramus block

Ultrasound-guided L5 dorsal ramus block

Outcome Measures

Primary Outcome Measures

Block accuracy [Immediately post-injection]
contrast distribution

Secondary Outcome Measures

Performance time [Perioperative]
Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.
Number of needle passes [Procedure]
Number of needle passes required to perform block

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Kelowna General Hospital	Kelowna	British Columbia	Canada	V1Y 1T2

Sponsors and Collaborators

Montreal General Hospital
University of British Columbia
Kelowna General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roderick Finlayson, Professor, Montreal General Hospital

ClinicalTrials.gov Identifier:

NCT03805906

Other Study ID Numbers:

2018-19-061-H

First Posted:

Jan 16, 2019

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Study Results

No Results Posted as of Sep 16, 2020