Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06731920

USG CMBB DSA Study

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Montreal General Hospital · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTcervical medial branch blockultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography

Timeline

Start date
2025-01-10
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2024-12-13
Last updated
2024-12-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06731920. Inclusion in this directory is not an endorsement.