CESI With Low Dose Lidocaine and Transient Weakness

NCT03127137 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STU00204980
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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 and patient satisfaction in the recovery phase after the injection procedure. Research Question: Does lidocaine versus saline as a steroid diluent effect objective upper extremity strength following cervical epidural steroid injection in patients being treated for cervical radiculitis? Null Hypothesis: Cervical epidural steroid injections that include local anesthetic as a diluent have no effect on objective upper extremity strength following the injection. We hypothesized that cervical epidural lidocaine will cause an objective decrease in strength in functional movements of the upper extremity.

Conditions

Cervical Radiculitis; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Strength in Both Groups After CESI.

  Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer.

  30 minutes after the CESI procedure

Secondary Outcomes (1)

• Number of Participants With Pain Reduction Post Procedure

  30 minutes after the CESI procedure.

Study Arms (2)

Experimental Group 1

ACTIVE COMPARATOR

Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)

Drug: Experimental Group 1 triamcinolone and lidocaine

Experimental Group 2

PLACEBO COMPARATOR

Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)

Drug: Experimental Group 2 triamcinolone and saline

Interventions

Experimental Group 1 triamcinolone and lidocaine DRUG

Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)

Also known as: Experimental Group 1

Experimental Group 1

Experimental Group 2 triamcinolone and saline DRUG

Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)

Also known as: Experimental Group 2

Experimental Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ages 18 years or older who will undergo CESI for treatment of cervical radiculitis

You may not qualify if:

• Patient refusal
• Lack of consent
• Any contraindication to CESI
• Inability to communicate with staff or to participate in follow up
• Inability to perform handgrip or arm strength testing
• Cervical spinal cord lesions
• Cerebrovascular, demyelinating or other neuromuscular muscular disease
• Patient request for or requirement of conscious sedation for the injection procedure
• Pregnancy
• Breast feeding
• Sensitivity to amides
• History of allergy to local anesthetics

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Peloso P, Gross A, Haines T, Trinh K, Goldsmith CH, Burnie S; Cervical Overview Group. Medicinal and injection therapies for mechanical neck disorders. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000319. doi: 10.1002/14651858.CD000319.pub4.

  PMID: 17636629 BACKGROUND

• Stav A, Ovadia L, Sternberg A, Kaadan M, Weksler N. Cervical epidural steroid injection for cervicobrachialgia. Acta Anaesthesiol Scand. 1993 Aug;37(6):562-6. doi: 10.1111/j.1399-6576.1993.tb03765.x.

  PMID: 8213020 BACKGROUND

• Cicala RS, Thoni K, Angel JJ. Long-term results of cervical epidural steroid injections. Clin J Pain. 1989 Jun;5(2):143-5. doi: 10.1097/00002508-198906000-00003.

  PMID: 2520395 BACKGROUND

• Botwin KP, Castellanos R, Rao S, Hanna AF, Torres-Ramos FM, Gruber RD, Bouchlas CG, Fuoco GS. Complications of fluoroscopically guided interlaminar cervical epidural injections. Arch Phys Med Rehabil. 2003 May;84(5):627-33. doi: 10.1016/s0003-9993(02)04862-1.

  PMID: 12736872 BACKGROUND

• Rowlingson JC, Kirschenbaum LP. Epidural analgesic techniques in the management of cervical pain. Anesth Analg. 1986 Sep;65(9):938-42.

  PMID: 3017152 BACKGROUND

• McCormick ZL, Burnham T, Cunningham S, Kendall RW, Bougie D, Teramoto M, Walega DR. Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial. Reg Anesth Pain Med. 2020 Oct;45(10):767-773. doi: 10.1136/rapm-2020-101598. Epub 2020 Aug 11.

  PMID: 32784231 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Post procedural strength was not assessed beyond 30 minutes. Pain and pain-related outcomes are subjective and variable. It may have been beneficial to have a global impression of change (PGIC)

Results Point of Contact

• Title: Paul C. Fitzgerald RN, BSN, MS
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• David Walega, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be blinded to group assignment. Outcome assessor will also be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Randomized Controlled Trial using control arm plus 2 arm experimental (placebo and active drug)

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: August 1, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 15, 2019
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)