Cervical Radiculopathy
Conditions
Keywords
cervical epidural steroid injection, local anesthetic, upper extremity weakness
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.
Interventions
PROCEDUREcervical interlaminar with lidocaine
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.
PROCEDUREcervical interlaminar with normal saline
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline
DRUGLidocaine
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
DRUGTriamcinolone Acetonide
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
DRUGNormal saline
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline. | 30 minutes post-procedure | Sensory Exam of upper extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Patient Global Impression of Change | one month follow up | 7 point question called Patient Global Impression of Change |
| Pain Medication | pre procedure, post-procedure, 1 day follow up, and one month follow up | Pain medication changes throughout treatment using MQS III calculator |
| Heart Rate Changes | 30 minutes post-procedure | Heart Rate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.
Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. | 10 |
| 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: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline
Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure. | 6 |
| Total | 16 |
Baseline characteristics
| Characteristic | Cervical Interlaminar With Normal Saline | Total | Cervical Interlaminar With Lidocaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 14 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 Participants | 16 Participants | 10 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 |
| other Total, other adverse events | 0 / 10 | 0 / 6 |
| serious Total, serious adverse events | 1 / 10 | 0 / 6 |
Outcome results
Primary
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
Time frame: 30 minutes post-procedure
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Primary
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Sensory Exam of upper extremity
Time frame: 30 minutes post-procedure
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Secondary
Heart Rate Changes
Heart Rate
Time frame: 30 minutes post-procedure
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Secondary
Mean Arterial Blood Pressure Changes
Mean Arterial Pressure
Time frame: 30 minutes post-procedure
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Secondary
Pain Intensity
Pain intensity will be measured by a 0-10 scale called Numerical Rating Scale. (0 being no pain and 10 being worst pain)
Time frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Secondary
Pain Medication
Pain medication changes throughout treatment using MQS III calculator
Time frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Secondary
Patient Global Impression of Change
7 point question called Patient Global Impression of Change
Time frame: one month follow up
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Secondary
Upper Extremity Functional Index
Upper Extremity Functional Index (UEFI) Questionnaire
Time frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Population: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.