A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Herniated Nucleus Pulposus Whiplash Injury |
Procedure: Cervical epidural steroid injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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 |
- 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)
- 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.
| Estimated Enrollment: | 25 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Jee Youn . Moon, M.D. | 82-10-5299-2036 ext 82-2-2072-2467 | jymoon0901@gmail.com |
| 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. | |
More Information
No publications provided
| 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 |
| Study First Received: | May 9, 2011 |
| Last Updated: | May 24, 2011 |
| Health Authority: | Institutional Review Board: South Korea |
Additional relevant MeSH terms:
|
Whiplash Injuries Intervertebral Disk Displacement Neck Injuries Wounds and Injuries Spinal Diseases |
Bone Diseases Musculoskeletal Diseases Hernia Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013