Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

Back Pain Clinical Trial

Official title:

Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00909272
• Other study ID #: 09-039-D
• Status: Withdrawn
• Phase: N/A
• First received: May 22, 2009
• Last updated: April 7, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block?

Description:

The diagnostic lumbar medial branch block for low back and radiating to lower extremity due to lumbar facet joint pain has been traditionally done under fluoroscopic guidance. Some recent studies have shown that the diagnostic lumbar medial branch may alternatively be done under ultrasound guidance. This proposed technique has many advantages, avoid radiation exposure and decrease waiting period for patients to have a pain procedure for low back pain. The time taken, patients' satisfaction score, pain score, the distance the needle tip placed under ultrasound and the ideal position visualized under fluoroscopy will be measured. This study will be done in 2 parts. The first part will determine landmarks for ultrasound. It will involve using 5 cadavers. The second part of the study will involve 25 patients. The needles will be placed initially with ultrasound and then will be verified with C-arm fluoroscopy. Certain criteria will be used to determine its feasibility, for example, less than 20 minutes, less than 5 mm.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Low back and/or leg pain due to possible lumbar facet joint disease

Exclusion Criteria:

• patient with BMI>35

• coagulopathy

• allergy to local anesthetic and ultrasound gel

• patient unable to fill out post procedure pain diary

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain

Intervention

Procedure:
• Lumbar medial branch block
The ultrasound probe will be placed perpendicular to skin along the midline of lumbar spinous process on longitudinal view first to count the lumbar level. The midpoint of each lumbar level will be marked on the longitudinal view and then will be rotated ninety degrees counter clockwise to axial view to locate the facet joint and the transverse process of lumbar spine. A #22 gauge 10cm long Quincke spinal needle will be inserted to the target area using in plane approach on the axial view. Then the probe will be rotated ninety degrees clockwise to longitudinal view to ensure needle tip is placed on the cephalad aspect of the transverse process. It will then be immediately confirmed by C-arm fluoroscopy on oblique view.
• Ultrasound landmarks
The target point is the superior medial aspect of transverse process of lumbar spine from L3 to S1. A #22 gauge 10cm long Quincke spinal needle will be use for needle placement. Needle placement will be visualized with ultrasound. Practice on cadavers with 3 different operators and see if results are reproducible. Verify with fluoroscopy.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences-General Location	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Shim JK, Moon JC, Yoon KB, Kim WO, Yoon DM. Ultrasound-guided lumbar medial-branch block: a clinical study with fluoroscopy control. Reg Anesth Pain Med. 2006 Sep-Oct;31(5):451-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perform a diagnostic lumbar medial branch block using ultrasound guidance, decide if it's practical to perform it, whether patients can tolerate it, can it be performed in a timely manner and the # of needle adjustments required to get target points.		At time of procedure	No
Secondary	Does this procedure correlate with other known procedures, by the distance between the needle tip placed under the ultrasound and the superior medial aspect of transverse process of lumbar spine L3 to S1 visualized under C-arm fluoroscopy.		At time of procedure	No