Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

Study Overview
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Brief Summary
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Does low-does cervical epidural lidocaine cause transient weakness?

Detailed Description
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Cervical radicular pain is relatively common, often treated with epidural steroid injection (ESI), when conservative treatments like oral analgesics, physical therapy, and activity modification have failed. There are no universal clinical practice guidelines for the use of diluents when CESI are performed. Interlaminar CESI may be performed with or without the use of local anesthetics, due to training bias or theoretical concerns of weakness. CESI without the benefit of local anesthetic as a steroid diluent increases the latency of pain relief and may decrease diagnostic information immediately after a CESI with regard to pain generators responsible for symptoms, and may potentially decrease patient satisfaction. By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI, we will enhance the safety of this treatment with regard to expectations of objective motor weakness as well as post procedure pain control in the recovery phase after the injection procedure. Additionally, investigation of short-term pain, function, medication use, and global impression of change following use of local anesthetic versus saline as a diluent during interlaminar cervical ESI will provide evidence to inform the optimization of clinical outcomes related to steroid diluent choice.

Official Title
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Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Procedure: cervical interlaminar with lidocaine
* Procedure: cervical interlaminar with normal saline
* Drug: Lidocaine
* Drug: Triamcinolone Acetonide
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80. Clinical diagnosis of cervical radicular pain. Magnetic resonance imaging pathology consistent with clinical symptoms/signs. Numerical Rating Scale (NRS) pain score of 4 or higher. Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care). Patients who will undergo CESI for treatment of cervical radiculitis. Exclusion Criteria: Refusal to participate, provide consent, or provide communication and follow-up information for duration of the study. Inability to perform handgrip or arm strength testing. Contraindications to Cervical ESI (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for CIESI, and pregnancy). Current glucocorticoid use or ESI within past 6 months. Prior cervical spine surgery. Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease. Patient request for or requirement of conscious sedation for the injection procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cervical interlaminar with lidocaine<br>Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL). | Procedure: cervical interlaminar with lidocaine<br>* Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.<br>* Other names: cervical epidural steroid injection;Drug: Lidocaine<br>* 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.<br>* Other names: Xylocaine;Drug: Triamcinolone Acetonide<br>* 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.<br>* Other names: Kenalog;|
| Active Comparator: cervical interlaminar with normal saline<br>Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL). | Procedure: cervical interlaminar with normal saline<br>* Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline<br>* Other names: cervical epidural steroid injection;Drug: Triamcinolone Acetonide<br>* 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.<br>* Other names: Kenalog;Drug: Normal saline<br>* 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.<br>* Other names: sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline. | Strength Testing Dynamometry post procedure with lidocaine vs normal saline. | 30 minutes post-procedure | 
| Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline. | Sensory Exam of upper extremity | 30 minutes post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Blood Pressure Changes | Mean Arterial Pressure | 30 minutes post-procedure | 
| Heart Rate Changes | Heart Rate | 30 minutes post-procedure | 
| Pain Intensity | Pain intensity will be measured by a 0-10 scale called Numerical Rating Scale. (0 being no pain and 10 being worst pain) | pre procedure, post-procedure, 1 day follow up, and one month follow up | 
| Upper Extremity Functional Index | Upper Extremity Functional Index (UEFI) Questionnaire | pre procedure, post-procedure, 1 day follow up, and one month follow up | 
| Pain Medication | Pain medication changes throughout treatment using MQS III calculator | pre procedure, post-procedure, 1 day follow up, and one month follow up | 
| Patient Global Impression of Change | 7 point question called Patient Global Impression of Change | one month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical epidural steroid injection, local anesthetic, upper extremity weakness