Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03382925
• Other study ID #: 106288
• Status: Terminated
• Phase: Phase 4
• Start date: December 20, 2017
• Est. completion date: August 19, 2020

Study information

• Verified date: November 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthenia
• Cervical Radiculopathy
• Radiculopathy

Intervention

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.
• 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

Drug:
• Lidocaine
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
• Triamcinolone Acetonide
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
• Normal saline
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.	Strength Testing Dynamometry post procedure with lidocaine vs normal saline.	30 minutes post-procedure
Primary	Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.	Sensory Exam of upper extremity	30 minutes post-procedure
Secondary	Mean Arterial Blood Pressure Changes	Mean Arterial Pressure	30 minutes post-procedure
Secondary	Heart Rate Changes	Heart Rate	30 minutes post-procedure
Secondary	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)	pre procedure, post-procedure, 1 day follow up, and one month follow up
Secondary	Upper Extremity Functional Index	Upper Extremity Functional Index (UEFI) Questionnaire	pre procedure, post-procedure, 1 day follow up, and one month follow up
Secondary	Pain Medication	Pain medication changes throughout treatment using MQS III calculator	pre procedure, post-procedure, 1 day follow up, and one month follow up
Secondary	Patient Global Impression of Change	7 point question called Patient Global Impression of Change	one month follow up