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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis

NCT04071483

Analgesia, Epidural

UNKNOWN NA

Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

NCT02838615

Spinal Stenosis

COMPLETED NA

Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

NCT03382821

Cervical Radiculopathy

COMPLETED PHASE4

Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

NCT03389620

Cervicogenic Upper Extremity Radiculopathy

COMPLETED PHASE2

Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

NCT03165825

Cervical Radiculopathy

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Herniated Nucleus Pulposus Whiplash Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

midline approach

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

Group Type ACTIVE_COMPARATOR

Cervical epidural steroid injection

Intervention Type PROCEDURE

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)

paramedian approach

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

Group Type ACTIVE_COMPARATOR

Cervical epidural steroid injection

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No