Clinical trial NCT03382925: Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
Official title: Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cervical Radiculopathy
Keywords: cervical epidural steroid injection
local anesthetic
upper extremity weakness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
timeFrame: 30 minutes post-procedure
measure: Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
timeFrame: 30 minutes post-procedure
Secondary outcomes:
measure: Mean Arterial Blood Pressure Changes
timeFrame: 30 minutes post-procedure
measure: Heart Rate Changes
timeFrame: 30 minutes post-procedure
measure: Pain Intensity
timeFrame: pre procedure, post-procedure, 1 day follow up, and one month follow up
measure: Upper Extremity Functional Index
timeFrame: pre procedure, post-procedure, 1 day follow up, and one month follow up
measure: Pain Medication
timeFrame: pre procedure, post-procedure, 1 day follow up, and one month follow up
measure: Patient Global Impression of Change
timeFrame: one month follow up
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Zachary L McCormick, MD
role: PRINCIPAL_INVESTIGATOR
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