CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 123 enrolled
Drug / intervention
Experimental Group 1 triamcinolone and lidocaine +1 moredrug
Likely dose
Experimental Group 1 triamcinolone and lidocaine 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03127137
NCT03127137Phase 4Completed

Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial

Northwestern University·interventional·Posted Apr 25, 2017·Updated Feb 10, 2023

In Brief

A Phase 4 clinical trial evaluating Experimental Group 1 triamcinolone and lidocaine and Experimental Group 2 triamcinolone and saline for Cervical Radiculitis and Pain. Completed, enrolled 123 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2017
Enrollment StartAug 1, 2018
Primary CompletionJun 6, 2019
Study CompletionJun 15, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.2 years ago

Interventions

Experimental Group 1 triamcinolone and lidocainedrug

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)

Experimental Group 2 triamcinolone and salinedrug

Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)