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Trial record 75 of 12496 for:    cervical

Cervical Epidural Pressure Measurement

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ClinicalTrials.gov Identifier: NCT01009385
Recruitment Status : Unknown
Verified November 2009 by Seoul National University Bundang Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 6, 2009
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Head Pain Neck Pain Upper Extremity Pain Procedure: cervical epidural steroid injection Procedure: epidural pressure measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Cervical Epidural Pressure Measurement: Comparison in the Prone and Sitting Positions
Study Start Date : October 2009
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Arm Intervention/treatment
Active Comparator: prone position 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
Other Name: cervical interlaminar epidural injection

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.
Other Name: a closed pressure measurement system

Active Comparator: sitting position 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
Other Name: cervical interlaminar epidural injection

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.
Other Name: a closed pressure measurement system




Primary Outcome Measures :
  1. cervical epidural pressure [ Time Frame: on interventional procedure (cervical epidural steroid injetion) ]

Secondary Outcome Measures :
  1. the angle of the neck flexion [ Time Frame: on interventional procedure (cervical epidural steroid injection) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009385


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Kumi, Kyonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jeeyoun Moon Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeeyoun Moon/Instructor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01009385     History of Changes
Other Study ID Numbers: snu23802
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009

Keywords provided by Seoul National University Bundang Hospital:
cervical
epidural
epidural pressure
monitoring

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms