CESI With Low Dose Lidocaine and Transient Weakness
Condition: Cervical Radiculitis; Pain
MeSH terms: Radiculopathy
Intervention: Experimental Group 1 triamcinolone and lidocaine; Experimental Group 2 triamcinolone and saline
Intervention description: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc); Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized Controlled Trial using control arm plus 2 arm experimental (placebo and active drug)
Masking: Double (Participant, Outcomes Assessor)
Masking description: Participant will be blinded to group assignment. Outcome assessor will also be blinded to the randomization.
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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