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A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches

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ClinicalTrials.gov Identifier: NCT01360138
Recruitment Status : Unknown
Verified May 2011 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : May 25, 2011
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by:
Seoul National University Bundang Hospital

Study Description
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Brief Summary:
Ligamentum flavum in the cervical region is thin or not fused at the midline. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs).

Condition or disease Intervention/treatment Phase
Herniated Nucleus Pulposus Whiplash Injury Procedure: Cervical epidural steroid injection Not Applicable

Detailed Description:
Ligamentum flavum in the cervical region is thin or not fused at the midline. The distinct elastic resistance offered by the ligamentum flavum before entering the epidural space when using the loss of resistance (LOR) technique may be blunted or even absent. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs). Therefore, the investigators randomly divide our patients into 2 groups; the midline approach group and the paramedian group. Then, the investigators examine the patterns of the pressure changes at the moment of a puncture of the ligamentum flavum during CESIs.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advantages of the Paramedian Approach for Cervical Epidural Steroid Injections: A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
Study Start Date : May 2011
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: midline approach
cervical epidural steroid injection with 18G Touhy epidural needle by midline approach
 Procedure: Cervical epidural steroid injection
cervical epidural steroid injection with a solution (5 ml) containing 10 mg triamcinolone acetonide suspension, 1.5 ml of 0.75% levobupivacaine hydrochloride, and 3.5 ml of normal saline (0.9% NaCl)
Active Comparator: paramedian approach
cervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach
 Procedure: Cervical epidural steroid injection
cervical epidural steroid injection with a solution (5 ml) containing 10 mg triamcinolone acetonide suspension, 1.5 ml of 0.75% levobupivacaine hydrochloride, and 3.5 ml of normal saline (0.9% NaCl)


Outcome Measures
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Primary Outcome Measures :
  1. precipitous decrease [ Time Frame: It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. ]
    Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)


Secondary Outcome Measures :
  1. popping sensation [ Time Frame: It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. ]
    Existence of the tactile sensation of give by pain experts (exist or not)

  2. spreading levels of dye according to dye volume [ Time Frame: It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. ]
    Dye Volume / Dye Spreading Level after injection of 0.5 cc contrast dye, then check the spreading level such as the number of vertebral body and unilateral or bilateral spreading

  3. cervical epidural pressure [ Time Frame: It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour. ]
    The bevel of the needle is considered to have entered the epidural space when a typical waveform is observed, which consists of small cardiac oscillations superimposed on greater respiratory oscillations. The needle is then held immobile in the epidural space for 120 s to allow the epidural pressure to stabilize, and CEP is measured.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20 to 80 yr
  • Cervical radicular pain caused by herniated nucleus pulposus, spinal steonosis, or other conditions, including herpes zoster-associated pain and whiplash injury for more than 3 months
  • Pain intensity > 4 of maximum 10 NRS
  • Failure to improve with conservative treatment
  • Cervical epidural location of needle confirmed by the fluoroscopic images

Exclusion Criteria:

  • Acute infection
  • Patient refusal
  • Previous cervical spine surgery
  • Structural spinal deformities or A space-occupying epidural mass
  • Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms that should prompt a reevaluation and surgical evaluation
  • Pregnancy
  • Allergy to contrast media or drugs to be used in the procedure
Contacts and Locations
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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): NCT01360138


Contacts
Contact: Jee Youn . Moon, M.D. 82-10-5299-2036 ext 82-2-2072-2467 jymoon0901@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jee Youn . Moon, M.D.    82-10-5299-2036    jymoon0901@gmail.com   
Principal Investigator: Jee Youn Moon, M.D.         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Seoul National University Hospital
More Information
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Responsible Party: Clinical Research Institute Seoul National University Hospital, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01360138     History of Changes
Other Study ID Numbers: jymoon0901
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries