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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 moreso than the antiinflammatory-only regimen.

Official Title
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Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department: A Prospective Randomized Controlled Study

Conditions
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Acute Musculoskeletal Disease, Sprains, Sprains and Strains, Injuries, Emergencies, Trauma, Acute Pain

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Lidocaine Patch 4%


Participation Criteria
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Eligibility Criteria
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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 7 days Subject's area of greatest pain isolated to one body part Subject does not have prior Emergency Department visits recorded on electronic medical records for the chief complaint 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 the trauma 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 to lidocaine or nonsteroidal antiinflammatory drugs, history of active GI bleeding or recent coronary artery bypass graft surgery precluding nonsteroidal antiinflammatory medications, severe hepatic disease (hepatitis, cirrhosis in current chart or prior history or elevation in liver function tests to clinically significant levels in past 6 months), severe kidney disease (Creatinine clearance less than 30 milliliters or history 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 reach the area of greatest pain to apply and reapply the patch Subject has prior history of chronic pain in the affected area (defined as greater than or equal to 6 weeks of pain) Subject has received opioid medication in triage area or within 4 hours of initial treatment 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 on the scale) Subject requires opiate medication or muscle relaxants (Flexeril, Valium, Tizanidine, Robaxin etc) during the initial visit to Emergency department at the discretion of the provider. Subjects who received less than 800 miligram oral dosage of ibuprofen in triage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>Ibuprofen 800mg every 8 hours for 3 days | Drug: Ibuprofen<br>* Ibuprofen tablet<br>* Other names: Advil;|
| Experimental: Ibuprofen & Lidocaine Patch 4%<br>Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days | Drug: Ibuprofen<br>* Ibuprofen tablet<br>* Other names: Advil;Drug: Lidocaine Patch 4%<br>* Lidocaine patch<br>* Other names: Lidocare Pain Relief Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numerical Pain Rating Scale | Change in self-reported pain intensity level. Baseline will be prior to intervention, and change will be assessed 30 minutes and 60 minutes after intervention, and at discharge. A repeat pain intensity level will also be asked 48-72 hours after discharge. This measure will also examine change of baseline numerical score from initial visit. Each item is scored 0-10 (0=No pain, 10= Worst pain possible). | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire (Yes or No) of Return Visit for Same Chief Complaint | Questionnaire (Yes or No) of whether a return visit to either the emergency department or primary care offices occurred within 1 week for same chief complaint from the initial visit | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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injury, muscle strain, muscle sprain, emergency department, acute pain