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

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).

Study Overview

• Status: Unknown
• Conditions: Whiplash Injury; Herniated Nucleus Pulposus
• Intervention / Treatment: Procedure: Cervical epidural steroid injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jee Youn . Moon, M.D.; Phone Number: 82-10-5299-2036; Email: jymoon0901@gmail.com
    • Principal Investigator: Jee Youn Moon, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 25, 2011
• Last Update Submitted That Met QC Criteria: May 24, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: jymoon0901