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Cervical Epidural Pressure Measurement

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01009385
Enrollment
30
Registered
2009-11-06
Start date
2009-10-31
Completion date
2009-11-30
Last updated
2009-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Pain, Neck Pain, Upper Extremity Pain

Keywords

cervical, epidural, epidural pressure, monitoring

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.

Interventions

* 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

PROCEDUREepidural 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.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
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.

Design outcomes

Primary

MeasureTime frame
cervical epidural pressureon interventional procedure (cervical epidural steroid injetion)

Secondary

MeasureTime frame
the angle of the neck flexionon interventional procedure (cervical epidural steroid injection)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026