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Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

Primary Purpose

Cervical Radiculopathy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
cervical interlaminar with lidocaine
cervical interlaminar with normal saline
Lidocaine
Triamcinolone Acetonide
Normal saline
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring cervical epidural steroid injection, local anesthetic, upper extremity weakness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

cervical interlaminar with lidocaine

cervical interlaminar with normal saline

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Sensory Exam of upper extremity

Secondary Outcome Measures

Mean Arterial Blood Pressure Changes
Mean Arterial Pressure
Heart Rate Changes
Heart Rate
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)
Upper Extremity Functional Index
Upper Extremity Functional Index (UEFI) Questionnaire
Pain Medication
Pain medication changes throughout treatment using MQS III calculator
Patient Global Impression of Change
7 point question called Patient Global Impression of Change

Full Information

First Posted
December 4, 2017
Last Updated
November 22, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03382925
Brief Title
Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
Official Title
Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
August 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
cervical epidural steroid injection, local anesthetic, upper extremity weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
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.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical interlaminar with lidocaine
Arm Type
Active Comparator
Arm Description
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).
Arm Title
cervical interlaminar with normal saline
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
cervical interlaminar with lidocaine
Other Intervention Name(s)
cervical epidural steroid injection
Intervention Description
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.
Intervention Type
Procedure
Intervention Name(s)
cervical interlaminar with normal saline
Other Intervention Name(s)
cervical epidural steroid injection
Intervention Description
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenalog
Intervention Description
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
sodium chloride
Intervention Description
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
Primary Outcome Measure Information:
Title
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
Description
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
Time Frame
30 minutes post-procedure
Title
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Description
Sensory Exam of upper extremity
Time Frame
30 minutes post-procedure
Secondary Outcome Measure Information:
Title
Mean Arterial Blood Pressure Changes
Description
Mean Arterial Pressure
Time Frame
30 minutes post-procedure
Title
Heart Rate Changes
Description
Heart Rate
Time Frame
30 minutes post-procedure
Title
Pain Intensity
Description
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
Title
Upper Extremity Functional Index
Description
Upper Extremity Functional Index (UEFI) Questionnaire
Time Frame
pre procedure, post-procedure, 1 day follow up, and one month follow up
Title
Pain Medication
Description
Pain medication changes throughout treatment using MQS III calculator
Time Frame
pre procedure, post-procedure, 1 day follow up, and one month follow up
Title
Patient Global Impression of Change
Description
7 point question called Patient Global Impression of Change
Time Frame
one month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80. Clinical diagnosis of cervical radicular pain. Magnetic resonance imaging pathology consistent with clinical symptoms/signs. Numerical Rating Scale (NRS) pain score of 4 or higher. Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care). Patients who will undergo CESI for treatment of cervical radiculitis. Exclusion Criteria: Refusal to participate, provide consent, or provide communication and follow-up information for duration of the study. Inability to perform handgrip or arm strength testing. Contraindications to Cervical ESI (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for CIESI, and pregnancy). Current glucocorticoid use or ESI within past 6 months. Prior cervical spine surgery. Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease. Patient request for or requirement of conscious sedation for the injection procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary L McCormick, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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