NCT03382925

Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Radiculopathy

Interventions

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

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-08-19
• Completion: 2020-08-19
• First posted: 2017-12-26
• Last updated: 2022-11-25
• Results posted: 2021-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study