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NCT03127137 · ClinicalTrials.gov registry record · Phase 4
CESI With Low Dose Lidocaine and Transient Weakness
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 123
- Enrollment target
NCT03127137: Completed Phase 4 study, sponsored by Northwestern University.
NCT03127137 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 123 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03127137, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 123 participants
- Enrollment target
Study 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.
Primary Outcome
Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer.
Interventions
- DRUG Experimental Group 1 triamcinolone and lidocaine
- DRUG Experimental Group 2 triamcinolone and saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2019-06-15 |
| Phase | Phase 4 |
What the finished NCT03127137 record still lists
NCT03127137 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Experimental Group 1 triamcinolone and lidocaine is the first listed.
NCT03127137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03127137 about?
NCT03127137 is a clinical study titled "CESI With Low Dose Lidocaine and 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 perf...
What is the current status of trial NCT03127137?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 123 participants. The study started on 2018-08-01. Estimated completion is 2019-06-15.
What interventions are being tested in trial NCT03127137?
The interventions under investigation include: Experimental Group 1 triamcinolone and lidocaine (DRUG), Experimental Group 2 triamcinolone and saline (DRUG).
Who is sponsoring clinical trial NCT03127137?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03127137's enrollment target sits among peer trials
123 662nd of 2000 higher than 1,336 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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