Cervical Epidural Pressure Measurement

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01009385
• Other study ID #: snu23802
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 4, 2009
• Last updated: November 5, 2009
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Head Pain
• Neck Pain
• Upper Extremity Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Kumi	Kyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cervical epidural pressure		on interventional procedure (cervical epidural steroid injetion)	No
Secondary	the angle of the neck flexion		on interventional procedure (cervical epidural steroid injection)	No