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
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMay 25, 2011
May 1, 2011
3 months
May 9, 2011
May 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
precipitous decrease
Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)
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.
Secondary Outcomes (3)
popping sensation
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.
spreading levels of dye according to dye volume
It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
cervical epidural pressure
It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
Study Arms (2)
midline approach
ACTIVE COMPARATORcervical epidural steroid injection with 18G Touhy epidural needle by midline approach
paramedian approach
ACTIVE COMPARATORcervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 25, 2011
Study Start
May 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
May 25, 2011
Record last verified: 2011-05