Herniated Nucleus Pulposus, Whiplash Injury
Conditions
Brief summary
Ligamentum flavum in the cervical region is thin or not fused at the midline. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs).
Detailed description
Ligamentum flavum in the cervical region is thin or not fused at the midline. The distinct elastic resistance offered by the ligamentum flavum before entering the epidural space when using the loss of resistance (LOR) technique may be blunted or even absent. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs). Therefore, the investigators randomly divide our patients into 2 groups; the midline approach group and the paramedian group. Then, the investigators examine the patterns of the pressure changes at the moment of a puncture of the ligamentum flavum during CESIs.
Interventions
PROCEDURECervical epidural steroid injection
cervical epidural steroid injection with a solution (5 ml) containing 10 mg triamcinolone acetonide suspension, 1.5 ml of 0.75% levobupivacaine hydrochloride, and 3.5 ml of normal saline (0.9% NaCl)
Sponsors
Seoul National University Hospital
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 80 yr * Cervical radicular pain caused by herniated nucleus pulposus, spinal steonosis, or other conditions, including herpes zoster-associated pain and whiplash injury for more than 3 months * Pain intensity \> 4 of maximum 10 NRS * Failure to improve with conservative treatment * Cervical epidural location of needle confirmed by the fluoroscopic images
Exclusion criteria
* Acute infection * Patient refusal * Previous cervical spine surgery * Structural spinal deformities or A space-occupying epidural mass * Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms that should prompt a reevaluation and surgical evaluation * Pregnancy * Allergy to contrast media or drugs to be used in the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| precipitous decrease | It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. | Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| popping sensation | It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. | Existence of the tactile sensation of give by pain experts (exist or not) |
| spreading levels of dye according to dye volume | It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. | Dye Volume / Dye Spreading Level after injection of 0.5 cc contrast dye, then check the spreading level such as the number of vertebral body and unilateral or bilateral spreading |
| cervical epidural pressure | It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. | The bevel of the needle is considered to have entered the epidural space when a typical waveform is observed, which consists of small cardiac oscillations superimposed on greater respiratory oscillations. The needle is then held immobile in the epidural space for 120 s to allow the epidural pressure to stabilize, and CEP is measured. |
Countries
South Korea
Contacts
Primary ContactJee Youn . Moon, M.D.
Outcome results
None listed