USG CMBB DSA Study

The Incidence of Inadvertent Intravascular Injection During Ultrasound-guided Cervical Medial Branch Blocks: a Fluoroscopically Controlled Study

Injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. This study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the needle. When this happens, it can go undetected because it does not make the patient feel any different, however it could cause a test block to be falsely negative, leading to the wrong diagnosis. Based on previous studies, we think that this happens rarely, and the purpose of this study is to prove that conclusively

Study Overview

• Status: Recruiting
• Conditions: Cervicalgia
• Intervention / Treatment: Diagnostic test: cervical medial branch block

Detailed Description

Cervical medial branch blocks (CMBB) are commonly employed for the diagnosis and management of facet-related pain. The latter constitutes the most important cause of axial neck pain and has been implicated in 40% of all cases. In addition, the upper cervical joints can also cause cervicogenic headaches, an often-debilitating condition representing up to 20% of chronic headaches3. Well-defined pain referral patterns for each joint can help operators select the appropriate injection level. While fluoroscopy has long been the imaging standard for spinal procedures, ultrasound guidance (USG) is being increasingly adopted as an alternative and presents several advantages such as the ability to identify and avoid soft tissue structures such as blood vessels during needle insertion. From a clinical perspective, avoiding blood vessels and reducing the incidence of vascular breach can lessen the occurrence of intravascular injections that are associated with false negative diagnostic blocks. Indeed, a recent study examining the safety of USG CMBB reported a lower incidence of vascular breach than previous studies that had used fluoroscopic guidance. While these findings suggested a potential benefit associated with USG, further confirmatory studies employing digital subtraction angiography (DSA), the current imaging standard to detect intravascular spread, are required. We hypothesize that USG will be associated will a lower incidence of intravascular spread during primary needle placement than has been reported with fluoroscopic guidance.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Roderick J Finlayson, MD; Phone Number: 250-860-9754; Email: roderick.finlayson@mac.com

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 0G1
      • Recruiting
      • Bill Nelems Pain and Research Centre
      • Contact: Roderick J Finlayson, MD; Phone Number: 250-860-9754; Email: roderick.finlayson@mac.com
      • Contact: Roderick J Finlayson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cervical medial branch blocks as part of their usual care.

Description

Inclusion Criteria:

Consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.

Exclusion Criteria:

Subjects with one or more of the following characteristics will be excluded from the study:

Known bleeding disorder or coagulopathy Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents) Inability to visualize targeted structures on ultrasound Known allergy to contrast agents

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main study group; Patients undergoing cervical medial branch blocks as part of their usual care.	Diagnostic test: cervical medial branch block; ultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of vascular uptake	Incidence of intravascular spread of contrast as determined after a review of the DSA sequences by a physician not involved in the patient's care.	During the course of needle placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed blood vessels	Number and distribution of vessels observed near the target.	During needle placement
Incidence of vascular breach	Incidence of vascular breach during needle placement.	During needle placement
Number of needle repositionings	Number of needle repositionings required (before and after DSA)	During needle placement
Complications	Occurrence of any block-related complications.	From beginning to completion of block procedure

Collaborators and Investigators

• Sponsor: Montreal General Hospital
• Collaborators: University of British Columbia
• Investigators: Principal Investigator: Roderick J Finlayson, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; safety; digital subtraction angiography; cervical medial branch block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2024-25-007-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
• product manufactured in and exported from the U.S.: No