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Completed

NCT Number: NCT03127137

CESI With Low Dose Lidocaine and Transient Weakness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

Experimental Groups: Prospective, randomized, controlled, double blinded trial in patients undergoing CESI for symptoms of cervical radiculitis.

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

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

Adults who are eligible to have a CESI with triamcinolone for treatment of cervical radiculitis at the Northwestern Anesthesiology Pain Medicine Center will be approached by authorized research personnel prior to a patient's CESI is performed and will obtain informed consent from patients who agree to participate.

In every subject (Group 1 and Group 2) a pre-procedure NRS pain score, and presence of subjective or objective symptoms of UE weakness will be recorded. Bilateral handgrip, wrist extension, elbow flexion, and elbow extension strength (myotomes C5-T1) will be measured by a trained research assistant prior to the injection procedure using a handheld JAMAR® PLUS+ digital dynamometer (Sammons Preston, Bollingbrook, IL) for hand grip strength and a push/pull handheld hydraulic dynamometer (Balego and Associates Inc., St. Paul, MN) for arm strength assessment. Three baseline strength measurements will be recorded for each strength test. Measurements will be taken prior to and 30 minutes following the injection procedure. Patients in Group #1 and Group #2 will also be queried with the Upper Extremity Functional Index (UEFI) before the injection procedure and again 1 day after the procedure (administered via telephone).

For Group 1 and Group 2, patients will be randomized to treatment group based on a random computer-generated schedule. Participants will be blinded to the group to which they are randomized. All standard procedures for CESIs will be followed as is standard practice including time out, skin prep, hemodynamic monitoring, image guidance etc.

Per randomization, triamcinolone acetonide 80 mg (Kenalog) (E. R. Squibb & Sons Limited, Uxbridge UK) will be combined with 2mL Lidocaine 1% or 2 mL preservative free saline and will be injected during the CESI procedure. In all cases, the total injectate volume will be 4 mL in all cases. All injections will be image guided with fluoroscopy, as is the current standard practice. Fluoroscopy time will be recorded.

The participant will be discharged from the clinic with written discharge instructions (current standard practice).

Participants will be telephoned by clinic personnel 1 day after the CESI to assess for subjective weakness in the hands or arms as well as any other adverse reactions. As above, the Upper Extremity Functional Index will be administered at this time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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)

Other names: 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)

Other names: Experimental Group 2

Primary outcomes

  1. Change in Strength in Both Groups After CESI.

    Time frame: 30 minutes after the CESI procedure

    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.

Secondary outcomes

  1. Number of Participants With Pain Reduction Post Procedure

    Time frame: 30 minutes after the CESI procedure.

    A greater than or equal to 50% reduction in change in average pain score before and after the CESI procedure.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2017
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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