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UnknownNCT01009385

Cervical Epidural Pressure Measurement

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Seoul National University Bundang Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREcervical 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
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.

Timeline

Start date
2009-10-01
Primary completion
2009-11-01
Completion
2009-11-01
First posted
2009-11-06
Last updated
2009-11-06

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01009385. Inclusion in this directory is not an endorsement.