The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 260
- Locations
- 2
- Primary Endpoint
- Intravascular injection
Study Overview
Brief Summary
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
Detailed Description
Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% ~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.
Exclusion Criteria
- •Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Outcomes
Primary Outcomes
Intravascular injection
Time Frame: During procedure
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
Secondary Outcomes
- Ventral epidural spreading(up to 24 weeks)
- Procedure time(During procedure)
- Medial epidural spreading(up to 24 weeks)
Investigators
Saeyoung Kim, MD, PhD
Professor
Kyungpook National University Hospital