Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?

NCT03382925 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 106288
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Radiculopathy

Keywords

cervical epidural steroid injection; local anesthetic; upper extremity weakness

Outcome Measures

Primary Outcomes (2)

• 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

• Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.

  Sensory Exam of upper extremity

  30 minutes post-procedure

Secondary Outcomes (6)

• Mean Arterial Blood Pressure Changes

  30 minutes post-procedure

• Heart Rate Changes

  30 minutes post-procedure

• Pain Intensity

  pre procedure, post-procedure, 1 day follow up, and one month follow up

• Upper Extremity Functional Index

  pre procedure, post-procedure, 1 day follow up, and one month follow up

• Pain Medication

  pre procedure, post-procedure, 1 day follow up, and one month follow up

Study Arms (2)

cervical interlaminar with lidocaine

ACTIVE COMPARATOR

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; Drug: Lidocaine; Drug: Triamcinolone Acetonide

cervical interlaminar with normal saline

ACTIVE COMPARATOR

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; Drug: Triamcinolone Acetonide; Drug: Normal saline

Interventions

cervical interlaminar with lidocaine PROCEDURE

Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.

Also known as: cervical epidural steroid injection

cervical interlaminar with lidocaine

cervical interlaminar with normal saline PROCEDURE

Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline

Also known as: cervical epidural steroid injection

cervical interlaminar with normal saline

Lidocaine DRUG

2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.

Also known as: Xylocaine

cervical interlaminar with lidocaine

Triamcinolone Acetonide DRUG

2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.

Also known as: Kenalog

cervical interlaminar with lidocaine; cervical interlaminar with normal saline

Normal saline DRUG

2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.

Also known as: sodium chloride

cervical interlaminar with normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (23)

• 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

• Ferrante FM, Wilson SP, Iacobo C, Orav EJ, Rocco AG, Lipson S. Clinical classification as a predictor of therapeutic outcome after cervical epidural steroid injection. Spine (Phila Pa 1976). 1993 May;18(6):730-6. doi: 10.1097/00007632-199305000-00010.

  PMID: 8516703 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

• Castagnera L, Maurette P, Pointillart V, Vital JM, Erny P, Senegas J. Long-term results of cervical epidural steroid injection with and without morphine in chronic cervical radicular pain. Pain. 1994 Aug;58(2):239-243. doi: 10.1016/0304-3959(94)90204-6.

  PMID: 7816491 BACKGROUND

• Lee SH, Kim KT, Kim DH, Lee BJ, Son ES, Kwack YH. Clinical outcomes of cervical radiculopathy following epidural steroid injection: a prospective study with follow-up for more than 2 years. Spine (Phila Pa 1976). 2012 May 20;37(12):1041-7. doi: 10.1097/BRS.0b013e31823b4d1f.

  PMID: 22024908 BACKGROUND

• McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521.

  PMID: 27922950 BACKGROUND

• Capdevila X, Biboulet P, Rubenovitch J, Serre-Cousine O, Peray P, Deschodt J, d'Athis F. The effects of cervical epidural anesthesia with bupivacaine on pulmonary function in conscious patients. Anesth Analg. 1998 May;86(5):1033-8. doi: 10.1097/00000539-199805000-00024.

  PMID: 9585292 BACKGROUND

• Bansal S, Turtle MJ. Inadvertent subdural spread complicating cervical epidural steroid injection with local anaesthetic agent. Anaesth Intensive Care. 2003 Oct;31(5):570-2. doi: 10.1177/0310057X0303100512.

  PMID: 14601282 BACKGROUND

• Collier CB. Accidental subdural block: four more cases and a radiographic review. Anaesth Intensive Care. 1992 May;20(2):215-25. doi: 10.1177/0310057X9202000218. No abstract available.

  PMID: 1317680 BACKGROUND

• Plastaras C, McCormick ZL, Garvan C, Macron D, Joshi A, Chimes G, Smeal W, Rittenberg J, Kennedy DJ. Adverse events associated with fluoroscopically guided lumbosacral transforaminal epidural steroid injections. Spine J. 2015 Oct 1;15(10):2157-65. doi: 10.1016/j.spinee.2015.05.034. Epub 2015 Jun 9.

  PMID: 26065819 BACKGROUND

• Ortiz MP, Godoy MC, Schlosser RS, Ortiz RP, Godoy JP, Santiago ES, Rigo FK, Beck V, Duarte T, Duarte MM, Menezes MS. Effect of endovenous lidocaine on analgesia and serum cytokines: double-blinded and randomized trial. J Clin Anesth. 2016 Dec;35:70-77. doi: 10.1016/j.jclinane.2016.07.021. Epub 2016 Aug 6.

  PMID: 27871598 BACKGROUND

• Gray A, Marrero-Berrios I, Weinberg J, Manchikalapati D, SchianodiCola J, Schloss RS, Yarmush J. The effect of local anesthetic on pro-inflammatory macrophage modulation by mesenchymal stromal cells. Int Immunopharmacol. 2016 Apr;33:48-54. doi: 10.1016/j.intimp.2016.01.019. Epub 2016 Feb 6.

  PMID: 26854576 BACKGROUND

• van der Wal SE, van den Heuvel SA, Radema SA, van Berkum BF, Vaneker M, Steegers MA, Scheffer GJ, Vissers KC. The in vitro mechanisms and in vivo efficacy of intravenous lidocaine on the neuroinflammatory response in acute and chronic pain. Eur J Pain. 2016 May;20(5):655-74. doi: 10.1002/ejp.794. Epub 2015 Dec 18.

  PMID: 26684648 BACKGROUND

• Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.

  PMID: 9014953 BACKGROUND

• Bohannon RW. Grip strength impairments among older adults receiving physical therapy in a home-care setting. Percept Mot Skills. 2010 Dec;111(3):761-4. doi: 10.2466/03.10.15.PMS.111.6.761-764.

  PMID: 21319615 BACKGROUND

• Hayes K, Walton JR, Szomor ZL, Murrell GA. Reliability of 3 methods for assessing shoulder strength. J Shoulder Elbow Surg. 2002 Jan-Feb;11(1):33-9. doi: 10.1067/mse.2002.119852.

  PMID: 11845146 BACKGROUND

• Kolber MJ, Beekhuizen K, Cheng MS, Fiebert IM. The reliability of hand-held dynamometry in measuring isometric strength of the shoulder internal and external rotator musculature using a stabilization device. Physiother Theory Pract. 2007 Mar-Apr;23(2):119-24. doi: 10.1080/09593980701213032.

  PMID: 17530541 BACKGROUND

• Awatani T, Mori S, Shinohara J, Koshiba H, Nariai M, Tatsumi Y, Nagata A, Morikita I. Same-session and between-day intra-rater reliability of hand-held dynamometer measurements of isometric shoulder extensor strength. J Phys Ther Sci. 2016 Mar;28(3):936-9. doi: 10.1589/jpts.28.936. Epub 2016 Mar 31.

  PMID: 27134388 BACKGROUND

• Fieseler G, Molitor T, Irlenbusch L, Delank KS, Laudner KG, Hermassi S, Schwesig R. Intrarater reliability of goniometry and hand-held dynamometry for shoulder and elbow examinations in female team handball athletes and asymptomatic volunteers. Arch Orthop Trauma Surg. 2015 Dec;135(12):1719-26. doi: 10.1007/s00402-015-2331-6. Epub 2015 Sep 19.

  PMID: 26386839 BACKGROUND

• Kirshblum SC, Waring W, Biering-Sorensen F, Burns SP, Johansen M, Schmidt-Read M, Donovan W, Graves D, Jha A, Jones L, Mulcahey MJ, Krassioukov A. Reference for the 2011 revision of the International Standards for Neurological Classification of Spinal Cord Injury. J Spinal Cord Med. 2011 Nov;34(6):547-54. doi: 10.1179/107902611X13186000420242.

  PMID: 22330109 BACKGROUND

• Kim JK, Park MG, Shin SJ. What is the minimum clinically important difference in grip strength? Clin Orthop Relat Res. 2014 Aug;472(8):2536-41. doi: 10.1007/s11999-014-3666-y. Epub 2014 May 10.

  PMID: 24817380 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Paresis

Interventions

Lidocaine; Saline Solution; Triamcinolone Acetonide; Sodium Chloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Early termination leading to low enrollment which ended up being the greatest limitation.

Results Point of Contact

• Title: Dr. Zachary McCormick
• Organization: University of Utah, Department of Physical Medicine and Rehabilitation

PMR.Research@hsc.utah.edu

801-587-5432

Study Officials

• Zachary L McCormick, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary L. McCormick, MD

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 26, 2017
• Study Start: December 20, 2017
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2020
• Last Updated: November 25, 2022
• Results First Posted: May 18, 2021

Record last verified: 2022-11

Locations

US (1)