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

Herniated Nucleus Pulposus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01360138
• Other study ID #: jymoon0901
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 24, 2011
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2011
• Source: Seoul National University Bundang Hospital
• Contact: Jee Youn . Moon, M.D.
• Phone: 82-10-5299-2036
• Email: jymoon0901[@]gmail.com
• Is FDA regulated: No
• Health authority: Institutional Review Board: South Korea
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herniated Nucleus Pulposus
• Intervertebral Disc Displacement
• Whiplash Injuries
• Whiplash Injury

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	popping sensation	Existence of the tactile sensation of give by pain experts (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.	No
Secondary	spreading levels of dye according to dye volume	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	It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.	No
Secondary	cervical epidural pressure	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.	It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.	No