Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

Phase 4

Terminated

Interventions: Procedure: cervical interlaminar with lidocaine
Procedure: cervical interlaminar with normal saline
Drug: Lidocaine
Drug: Normal saline
Drug: Triamcinolone Acetonide

Brief Summary: "Does low-does cervical epidural lidocaine cause transient weakness?"

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
cervical interlaminar with lidocaine	cervical interlaminar with lidocaine	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).
cervical interlaminar with normal saline	cervical interlaminar with normal saline	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).
cervical interlaminar with normal saline	Normal saline	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).
cervical interlaminar with lidocaine	Triamcinolone Acetonide	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).
cervical interlaminar with lidocaine	Lidocaine	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).
cervical interlaminar with normal saline	Triamcinolone Acetonide	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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