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

History of Changes

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

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

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 (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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 Disc Displacement Neck Injuries Wounds and Injuries Spinal Diseases	Bone Diseases Musculoskeletal Diseases Hernia Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 28, 2016

To Top