Cervical Epidural Pressure Measurement

NCT ID: NCT01009385

Last Updated: 2009-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Head Pain; Neck Pain; Upper Extremity Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

prone position

Group Type: ACTIVE_COMPARATOR

cervical epidural steroid injection

Intervention Type: PROCEDURE

• 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

Intervention Type: PROCEDURE

• 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.

sitting position

Group Type: ACTIVE_COMPARATOR

cervical epidural steroid injection

Intervention Type: PROCEDURE

• 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

Intervention Type: PROCEDURE

• 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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

cervical interlaminar epidural injection; a closed pressure measurement system

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Bundang Hospital

Principal Investigators

Jeeyoun Moon

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Kŭmi, Kyonggi-do, South Korea

Countries

South Korea

References

Joo Y, Moon JY, Kim YC, Lee SC, Kim HY, Park SY. A pressure comparison between midline and paramedian approaches to the cervical epidural space. Pain Physician. 2014 Mar-Apr;17(2):155-62.

Reference Type: DERIVED

PMID: 24658476 (View on PubMed)

Moon JY, Lee PB, Nahm FS, Kim YC, Choi JB. Cervical epidural pressure measurement: comparison in the prone and sitting positions. Anesthesiology. 2010 Sep;113(3):666-71. doi: 10.1097/ALN.0b013e3181e898e8.

Reference Type: DERIVED

PMID: 20693880 (View on PubMed)

Other Identifiers

snu23802

Identifier Type: -

Identifier Source: org_study_id