Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

November 22, 2022 updated by: Zack McCormick, University of Utah

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

"Does low-does cervical epidural lidocaine cause transient weakness?"

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Procedure: 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.
Other Names:
  • cervical epidural steroid injection
Drug: Lidocaine
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
Other Names:
  • Xylocaine
Drug: Triamcinolone Acetonide
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
Other Names:
  • Kenalog
Active Comparator: 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).
Drug: Triamcinolone Acetonide
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
Other Names:
  • Kenalog
Procedure: 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
Other Names:
  • cervical epidural steroid injection
Drug: Normal saline
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
Other Names:
  • sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
Time Frame: 30 minutes post-procedure
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
30 minutes post-procedure
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Time Frame: 30 minutes post-procedure
Sensory Exam of upper extremity
30 minutes post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Blood Pressure Changes
Time Frame: 30 minutes post-procedure
Mean Arterial Pressure
30 minutes post-procedure
Heart Rate Changes
Time Frame: 30 minutes post-procedure
Heart Rate
30 minutes post-procedure
Pain Intensity
Time Frame: 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)
pre procedure, post-procedure, 1 day follow up, and one month follow up
Upper Extremity Functional Index
Time Frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Upper Extremity Functional Index (UEFI) Questionnaire
pre procedure, post-procedure, 1 day follow up, and one month follow up
Pain Medication
Time Frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Pain medication changes throughout treatment using MQS III calculator
pre procedure, post-procedure, 1 day follow up, and one month follow up
Patient Global Impression of Change
Time Frame: one month follow up
7 point question called Patient Global Impression of Change
one month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Zachary L McCormick, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Actual)

August 19, 2019

Study Completion (Actual)

August 19, 2020

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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