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

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: November 2009

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.

Intervention(s) in this Clinical Trial

• Procedure: cervical epidural steroid injection
  • 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
• Procedure: epidural pressure measurement
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: prone position
• Active Comparator: sitting position

Primary Measures

• cervical epidural pressure
  • Time Frame: on interventional procedure (cervical epidural steroid injetion)
    Safety Issue?: No

Secondary Measures

• the angle of the neck flexion
  • Time Frame: on interventional procedure (cervical epidural steroid injection)
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Seoul National University Bundang Hospital

Overall Clinical Trial Officials and Contacts

Jeeyoun Moon Principal Investigator Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01009385

Study ID Number: snu23802

ClinicalTrials.gov Identifier: NCT01009385

Health Authority: Korea: Institutional Review Board