A Phase 4 interventional study of cervical interlaminar with lidocaine and cervical interlaminar with normal saline in Cervical Radiculopathy, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by University of Utah · Phase 4, Interventional, and Treatment
"Does low-does cervical epidural lidocaine cause transient weakness?"
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.
Exclusion Criteria:
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).
Procedure: cervical interlaminar with lidocaine · Drug: Lidocaine · Drug: Triamcinolone Acetonide
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).
Procedure: cervical interlaminar with normal saline · Drug: Triamcinolone Acetonide · Drug: Normal saline
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.
Also known as: cervical epidural steroid injection
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline
Also known as: cervical epidural steroid injection
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
Also known as: Xylocaine
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
Also known as: Kenalog
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
Also known as: sodium chloride
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
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Sensory Exam of upper extremity
Time frame: 30 minutes post-procedure
Mean Arterial Blood Pressure Changes
Mean Arterial Pressure
Time frame: 30 minutes post-procedure
Heart Rate Changes
Heart Rate
Time frame: 30 minutes post-procedure
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
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
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
Patient Global Impression of Change
7 point question called Patient Global Impression of Change
Time frame: one month follow up
| Milestone | Cervical Interlaminar With Lidocaine | Cervical Interlaminar With Normal Saline |
|---|---|---|
| Started | 10 | 6 |
| Completed | 10 | 6 |
| Not completed | 0 | 0 |
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
No measurements were reported for this outcome.
Sensory Exam of upper extremity
No measurements were reported for this outcome.
Mean Arterial Pressure
No measurements were reported for this outcome.
Heart Rate
No measurements were reported for this outcome.
Pain intensity will be measured by a 0-10 scale called Numerical Rating Scale. (0 being no pain and 10 being worst pain)
No measurements were reported for this outcome.
Upper Extremity Functional Index (UEFI) Questionnaire
No measurements were reported for this outcome.
Pain medication changes throughout treatment using MQS III calculator
No measurements were reported for this outcome.
7 point question called Patient Global Impression of Change
No measurements were reported for this outcome.
Collected over Adverse event data was collected on each participant from their first day of enrollment until one month post procedure (Timeframe was approximately 1 1/2 months for each participant from enrollment, strength testing/procedure, to one month follow up). Duration of study enrollment was from December 20, 2017 to August 19, 2020 when study enrollment was closed.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervical Interlaminar With Lidocaine | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) |
| Cervical Interlaminar With Normal Saline | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Event | Cervical Interlaminar With Lidocaine | Cervical Interlaminar With Normal Saline |
|---|---|---|
| Procedure AECardiac disorders | 1/10 | 0/6 |
| Age, Categorical(Participants) | Cervical Interlaminar With Lidocaine | Cervical Interlaminar With Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 6 | 14 |
| >=65 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | Cervical Interlaminar With Lidocaine | Cervical Interlaminar With Normal Saline | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 5 | 2 | 7 |
| Race and Ethnicity Not Collected(Participants) | Cervical Interlaminar With Lidocaine | Cervical Interlaminar With Normal Saline | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Cervical Interlaminar With Lidocaine | Cervical Interlaminar With Normal Saline | Total |
|---|---|---|---|
| United States | 10 | 6 | 16 |
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University of Utah