Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department

Last updated: March 3, 2024
Sponsor: East Carolina University
Overall Status: Completed

Phase

3

Condition

Acute Pain

Sprains

Pain

Treatment

Ibuprofen

Lidocaine Patch 4%

Clinical Study ID

NCT03571737
UMCIRB 17-001594
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study evaluates the addition of a lidocaine patch to ibuprofen in the treatment of acute musculoskeletal pains. Half of the participants will get only ibuprofen for their pain, while other half will receive lidocaine patch plus the ibuprofen. After addition of the pain medications, the participants will be followed for their pain scores and return visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject's age is greater than or equal to 18 years old
  • Subject is able to speak English
  • Subject has chief complaint of musculoskeletal pain lasting less than or equal to 7days
  • Subject's area of greatest pain isolated to one body part
  • Subject does not have prior Emergency Department visits recorded on electronic medicalrecords for the chief complaint

Exclusion

Exclusion Criteria:

  • Subject's age is less than 18 years old
  • Subject is pregnant or breastfeeding patients
  • Subject cannot speak English
  • Subject has multiple traumatic injuries or injury requiring consultation with thetrauma service per study facility's guidelines
  • Subject has cellulitis or infection overlying the injuries
  • Subject has open wound overlying the injuries
  • Subject's chief complaint is caused by penetrating injury
  • Subject has absolute contraindications to study medications, including anaphylaxis tolidocaine or nonsteroidal antiinflammatory drugs, history of active GI bleeding orrecent coronary artery bypass graft surgery precluding nonsteroidal antiinflammatorymedications, severe hepatic disease (hepatitis, cirrhosis in current chart or priorhistory or elevation in liver function tests to clinically significant levels in past 6 months), severe kidney disease (Creatinine clearance less than 30 milliliters orhistory of chronic kidney disease stage 3 or worse), congestive heart failure.
  • Subject has medication contraindications such as concurrent use of medications listed:Alcuronium, Amphotericin B, Amprenavir, Atracurium, Cimetidine, Edrophonium,Enflurane, Fosphenytoin, Halothane, Nadolol, Oxprenolol, Pentazocine, Propafenone
  • Subject is on class I antiarrhythmics therapy (including lidocaine, procainamide,disopyramide etc)
  • Subject has injuries requiring splint/casting where patient may not be able to reachthe area of greatest pain to apply and reapply the patch
  • Subject has prior history of chronic pain in the affected area (defined as greaterthan or equal to 6 weeks of pain)
  • Subject has received opioid medication in triage area or within 4 hours of initialtreatment
  • Subject is unable to give pain scores due to mental status
  • Subject's initial numerical pain scale score of 0 (which would constitute "no pain" onthe scale)
  • Subject requires opiate medication or muscle relaxants (Flexeril, Valium, Tizanidine,Robaxin etc) during the initial visit to Emergency department at the discretion of theprovider.
  • Subjects who received less than 800 milligram oral dosage of ibuprofen in triage

Study Design

Total Participants: 23
Treatment Group(s): 2
Primary Treatment: Ibuprofen
Phase: 3
Study Start date:
June 23, 2018
Estimated Completion Date:
January 30, 2021

Study Description

Ibuprofen and other nonsteroidal antiinflammatory pain medications have been traditionally used for relief of mild to moderate acute musculoskeletal pains. However, if this medication did not work, a different modality for pain control would be added to the original regimen. In recent times, lidocaine patch has been introduced as a separate modality for pain control. This medication is thought to help by selectively inhibiting voltage-gated sodium channels in nociceptors involved in pain response. Given the separate modality, it would be prudent to see whether the addition of lidocaine patch to the ibuprofen would help relieve the pain more so than the antiinflammatory-only regimen.

Connect with a study center

  • Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

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