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

Primary Purpose

Herniated Nucleus Pulposus, Whiplash Injury

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cervical epidural steroid injection
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herniated Nucleus Pulposus

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

midline approach

paramedian approach

Arm Description

cervical epidural steroid injection with 18G Touhy epidural needle by midline approach

cervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach

Outcomes

Primary Outcome Measures

precipitous decrease
Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)

Secondary Outcome Measures

popping sensation
Existence of the tactile sensation of give by pain experts (exist or not)
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
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.

Full Information

First Posted
May 9, 2011
Last Updated
May 24, 2011
Sponsor
Seoul National University Bundang Hospital
Collaborators
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01360138
Brief Title
A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Nucleus Pulposus, Whiplash Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
midline approach
Arm Type
Active Comparator
Arm Description
cervical epidural steroid injection with 18G Touhy epidural needle by midline approach
Arm Title
paramedian approach
Arm Type
Active Comparator
Arm Description
cervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach
Intervention Type
Procedure
Intervention Name(s)
Cervical epidural steroid injection
Intervention Description
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)
Primary Outcome Measure Information:
Title
precipitous decrease
Description
Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)
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.
Secondary Outcome Measure Information:
Title
popping sensation
Description
Existence of the tactile sensation of give by pain experts (exist or not)
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.
Title
spreading levels of dye according to dye volume
Description
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
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.
Title
cervical epidural pressure
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jee Youn . Moon, M.D.
Phone
82-10-5299-2036
Ext
82-2-2072-2467
Email
jymoon0901@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Youn . Moon, M.D.
Phone
82-10-5299-2036
Email
jymoon0901@gmail.com
First Name & Middle Initial & Last Name & Degree
Jee Youn Moon, M.D.

12. IPD Sharing Statement

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

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