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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Herniated Nucleus Pulposus Whiplash Injury | Procedure: Cervical epidural steroid injection | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: midline approach
cervical epidural steroid injection with 18G Touhy epidural needle by midline approach
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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)
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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)
|
- 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)
- 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)
- 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
- 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.

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
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. |
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 |