Cervical Epidural Pressure Measurement

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01009385

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

29.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Head Pain Neck Pain Upper Extremity Pain	Procedure: cervical epidural steroid injection Procedure: epidural pressure measurement	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2009

Anticipated Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: prone position	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 Other Names: cervical interlaminar epidural injection 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. Other Names: a closed pressure measurement system
Active Comparator: sitting position	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 Other Names: cervical interlaminar epidural injection 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. Other Names: a closed pressure measurement system

Arm

Intervention/Treatment

Active Comparator: prone position

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

Other Names:

cervical interlaminar epidural injection

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.

Other Names:

a closed pressure measurement system

Active Comparator: sitting position

Procedure: cervical epidural steroid injection

Other Names:

cervical interlaminar epidural injection

Procedure: epidural pressure measurement

Other Names:

a closed pressure measurement system

Outcome Measures

Primary Outcome Measures

cervical epidural pressure [on interventional procedure (cervical epidural steroid injetion)]

Secondary Outcome Measures

the angle of the neck flexion [on interventional procedure (cervical epidural steroid injection)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.