Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles

Study Overview
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Brief Summary
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The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Detailed Description
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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.

Official Title
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The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study

Conditions
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Analgesia, Epidural

Intervention / Treatment
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* Device: Straight needle
* Device: Bent needle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Straight needle<br>25 gauge straight chiba needle | Device: Straight needle<br>* Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, straight needle is going to be used.<br>|
| Active Comparator: Bent needle<br>25 gauge bent chiba needle | Device: Bent needle<br>* Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, bent needle is going to be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravascular injection | Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventral epidural spreading | Ventral epidural spreading is defined when the contrast reached just behind the vertebral body in fluoroscopic lateral view. | up to 24 weeks | 
| Medial epidural spreading | Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin | up to 24 weeks | 
| Procedure time | Procedure time is defined as the time from the point when the block needle passed through the skin to observation of the complete contrast flow pattern with real time fluoroscopy. | During procedure |