Clinical trial NCT01009385: Cervical Epidural Pressure Measurement
Official title: Cervical Epidural Pressure Measurement: Comparison in the Prone and Sitting Positions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head Pain
Neck Pain
Upper Extremity Pain
Keywords: cervical
epidural
epidural pressure
monitoring
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: cervical epidural pressure
timeFrame: on interventional procedure (cervical epidural steroid injetion)
Secondary outcomes:
measure: the angle of the neck flexion
timeFrame: on interventional procedure (cervical epidural steroid injection)
Other outcomes:
Locations:
city: Kumi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyonggi-do
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
name: Jeeyoun Moon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.