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Trial record 54 of 12488 for:    cervical

Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

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ClinicalTrials.gov Identifier: NCT03382925
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Utah

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

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Procedure: cervical interlaminar with lidocaine Procedure: cervical interlaminar with normal saline Drug: Lidocaine Drug: Triamcinolone Acetonide Drug: Normal saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine


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 Name: cervical epidural steroid injection

Drug: Lidocaine
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
Other Name: 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 Name: 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).
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 Name: cervical epidural steroid injection

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 Name: Kenalog

Drug: Normal saline
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
Other Name: sodium chloride




Primary Outcome Measures :
  1. Changes in dynamometer testing pre and post procedure with lidocaine vs normal saline. [ Time Frame: pre-procedure and 30 minutes post-procedure ]
    Strength Testing Dynamometry

  2. Sensory Exam testing pre and post procedure with lidocaine vs normal saline. [ Time Frame: pre procedure and 30 minutes post-procedure ]
    Sensory Exam of upper extremity


Secondary Outcome Measures :
  1. Mean Arterial Blood Pressure Changes [ Time Frame: pre procedure and 30 minutes post-procedure ]
    Mean Arterial Pressure

  2. Heart Rate Changes [ Time Frame: pre procedure and 30 minutes post-procedure ]
    Heart Rate

  3. 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 (NRS)

  4. 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

  5. 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

  6. Patient Global Impression of Change [ Time Frame: one month follow up ]
    7 point question called Patient Global Impression of Change



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382925


Contacts
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Contact: Shellie S Cunningham, BS 801-587-5488 shellie.cunningham@hsc.utah.edu
Contact: Matthew J Brobeck, AS 801-587-5488 matthew.brobeck@hsc.utah.edu

Locations
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United States, Utah
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shellie S Cunningham, BS    801-587-5488    shellie.cunningham@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Zachary L McCormick, MD University of Utah

Publications:

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03382925     History of Changes
Other Study ID Numbers: 106288
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Utah:
cervical epidural steroid injection
local anesthetic
upper extremity weakness

Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors