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

• Status: Recruiting
• Trial end date: 2022-01-15
• Target enrollment: 0
• Participant gender: All

Summary

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 and patient satisfaction in the recovery phase after the injection procedure.

Research Question:

Does lidocaine versus saline as a steroid diluent effect objective upper extremity strength following cervical epidural steroid injection in patients being treated for cervical radiculitis?

Null Hypothesis:

Cervical epidural steroid injections that include local anesthetic as a diluent have no effect on objective upper extremity strength following the injection.

We hypothesized that cervical epidural lidocaine will cause an objective decrease in strength in functional movements of the upper extremity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• All patients ages 18 years or older who will undergo CESI for treatment of cervical radiculitis

Exclusion Criteria:

• Patient refusal

• Lack of consent

• Any contraindication to CESI

• Inability to communicate with staff or to participate in follow up

• Inability to perform handgrip or arm strength testing

• Cervical spinal cord lesions

• Cerebrovascular, demyelinating or other neuromuscular muscular disease

• Patient request for or requirement of conscious sedation for the injection procedure

• Pregnancy

• Breast feeding

• Sensitivity to amides

• History of allergy to local anesthetics