Analgesia, Epidural
Conditions
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.
Interventions
DEVICEStraight needle
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.
DEVICEBent needle
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.
Sponsors
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intravascular injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Ventral epidural spreading | up to 24 weeks | Ventral epidural spreading is defined when the contrast reached just behind the vertebral body in fluoroscopic lateral view. |
| Medial epidural spreading | up to 24 weeks | Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin |
| Procedure time | During procedure | 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. |
Countries
South Korea
Contacts
Primary ContactJimin Heo
Backup ContactSaeyoung Kim
Outcome results
None listed