Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients

Cook County Health

Status and phase: Withdrawn; Phase 4

Conditions: Low Back Pain

Treatments: Drug: lidocaine 5% patch; Drug: standard therapy; Drug: Non-medicated patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03301766

17-510

Details and patient eligibility

About

This study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the Emergency Department. In addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.

Full description

Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have been evaluated in the treatment of ED patients with low back pain including acetaminophen, NSAIDS, opioids, steroids, and muscle relaxants.

Lidocaine is a local anesthetic that can be administered by various routes. It is used in a transdermal patch for the treatment of pain. It is commonly used for focal causes of pain, including low back pain. The addition of lidocaine 5% patches to standard low back pain therapy has not been rigorously evaluated, although it is frequently used.

Sex: All

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pain originating between the lower border of the scapulae and the upper gluteal folds
• treating ED physician plan for discharge of the patient

Exclusion criteria

• radicular pain defined as pain radiating below the gluteal folds
• direct trauma to the back within previous month
• pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the past 3 months
• patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls
• known allergy to lidocaine or skin breakdown over site of pain
• treating physician plan for opioid prescription (tramadol, codeine, hydrocodone)
• personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery
• patients who are detainees
• previous enrollment in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Lidocaine 5% patch

Experimental group

Description:

Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.

Treatment:

Drug: standard therapy

Drug: lidocaine 5% patch

Non-medicated patch

Active Comparator group

Description:

Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.

Treatment:

Drug: Non-medicated patch

Drug: standard therapy