Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 4

Conditions: Cervical Radiculopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03382925

106288

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80.
2. Clinical diagnosis of cervical radicular pain.
3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
4. Numerical Rating Scale (NRS) pain score of 4 or higher.
5. Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
6. Patients who will undergo CESI for treatment of cervical radiculitis.

Exclusion criteria

1. Refusal to participate, provide consent, or provide communication and follow-up information for duration of the study.
2. Inability to perform handgrip or arm strength testing.
3. Contraindications to Cervical ESI (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for CIESI, and pregnancy).
4. Current glucocorticoid use or ESI within past 6 months.
5. Prior cervical spine surgery.
6. Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
7. Patient request for or requirement of conscious sedation for the injection procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

cervical interlaminar with lidocaine

Active Comparator group

Description:

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).

Treatment:

Drug: Triamcinolone Acetonide

Procedure: cervical interlaminar with lidocaine

Drug: Lidocaine

cervical interlaminar with normal saline

Active Comparator group

Description:

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).

Treatment:

Drug: Triamcinolone Acetonide

Procedure: cervical interlaminar with normal saline

Drug: Normal saline