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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01360138
First received: May 9, 2011
Last updated: May 24, 2011
Last verified: May 2011

May 9, 2011
May 24, 2011
May 2011
August 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)
Same as current
Complete list of historical versions of study NCT01360138 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    Existence of the tactile sensation of give by pain experts (exist or not)
  • 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. ] [ Designated as safety issue: No ]
    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
  • 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. ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
Advantages of the Paramedian Approach for Cervical Epidural Steroid Injections: A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Herniated Nucleus Pulposus
  • Whiplash Injury
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: midline approach
    cervical epidural steroid injection with 18G Touhy epidural needle by midline approach
    Intervention: Procedure: Cervical epidural steroid injection
  • Active Comparator: paramedian approach
    cervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach
    Intervention: Procedure: Cervical epidural steroid injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Jee Youn . Moon, M.D. 82-10-5299-2036 ext 82-2-2072-2467 jymoon0901@gmail.com
Korea, Republic of
 
NCT01360138
jymoon0901
Yes
Clinical Research Institute Seoul National University Hospital, Seoul National University Hospital
Seoul National University Bundang Hospital
Seoul National University Hospital
Not Provided
Seoul National University Bundang Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP