Cervical Epidural Pressure Measurement

Study Overview
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Brief Summary
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Cervical epidural steroid injections The hanging drop (HD) technique is commonly used for identifying the cervical epidural space. The hanging drop (HD) technique is using the negative pressure in the epidural space. The subject of debate whether the epidural space exhibits negative pressure. In a previous study, EP might be influenced by body position No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now. The hypothesis of this study There is a difference in the cervical epidural pressure between in the prone and sitting positions To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups. Using a closed pressure measurement system Under fluoroscopic guidance.

Detailed Description
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Cervical epidural steroid injections (CESIs) For the conservative management of head, neck, and upper extremity pain Important to identify the epidural space for minimizing the chance of a dural puncture injection Dural puncture injection makes CESIs prone to rare but catastrophic complication like permanent spinal cord injury The hanging drop (HD) technique Commonly used for identifying the cervical epidural space Using the negative pressure in the epidural space The subject of debate whether the epidural space exhibits negative pressure In previous studies using a closed pressure measurement systems The epidural pressure (EP) was commonly positive at the thoracic level in the lateral decubitus position. EP was consistently negative only in the sitting position. EP might be influenced by body position. The patient should be sitting for using the HD technique. No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now. The hypothesis of this study There is a difference in the cervical epidural pressure between in the prone and sitting positions To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups. Using a closed pressure measurement system Under fluoroscopic guidance.

Official Title
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Cervical Epidural Pressure Measurement: Comparison in the Prone and Sitting Positions

Conditions
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Head Pain, Neck Pain, Upper Extremity Pain

Intervention / Treatment
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* Procedure: cervical epidural steroid injection
* Procedure: epidural pressure measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cervical radicular pain caused by herniated nucleus pulpous and spinal stenosis other conditions including herpes zoster-associated pain and sprain. Exclusion Criteria: contraindications for CESIs, such as coagulopathy, patient refusal or infection at the proposed insertion site previous cervical spinal surgery pregnancy.

Ages Eligible for Study
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Minimum Age: 18 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prone position<br> | Procedure: cervical epidural steroid injection<br>* After aseptic preparation and skin infiltration with 1% lidocaine 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level identification of the epidural space confirmed by injection of contrast medium under fluoroscope injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl). Post-procedure, patients were observed for any adverse effects and followed with a neurological examination<br>* Other names: cervical interlaminar epidural injection;Procedure: epidural pressure measurement<br>* The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view. Identification of the epidural space and measurement of EP was performed with a closed measurement system.<br>* Other names: a closed pressure measurement system;|
| Active Comparator: sitting position<br> | Procedure: cervical epidural steroid injection<br>* After aseptic preparation and skin infiltration with 1% lidocaine 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level identification of the epidural space confirmed by injection of contrast medium under fluoroscope injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl). Post-procedure, patients were observed for any adverse effects and followed with a neurological examination<br>* Other names: cervical interlaminar epidural injection;Procedure: epidural pressure measurement<br>* The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view. Identification of the epidural space and measurement of EP was performed with a closed measurement system.<br>* Other names: a closed pressure measurement system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical epidural pressure |  | on interventional procedure (cervical epidural steroid injetion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the angle of the neck flexion |  | on interventional procedure (cervical epidural steroid injection) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical, epidural, epidural pressure, monitoring