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

Phase 3

Completed

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

Interventions: Drug: Ibuprofen
Drug: Lidocaine Patch 4%

Registration Number: NCT03571737

Lead Sponsor: East Carolina University

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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 milligram oral dosage of ibuprofen in triage

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen	Ibuprofen 800mg every 8 hours for 3 days
Ibuprofen & Lidocaine Patch 4%	Ibuprofen	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
Ibuprofen & Lidocaine Patch 4%	Lidocaine Patch 4%	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

Primary Outcome Measures

Name	Time	Method
Change in Numerical Pain Rating Scale	60 minutes	Change in self-reported pain intensity level. Baseline will be prior to intervention, and change will be assessed 60 minutes after intervention. Each item is scored 0-10 (0=No pain, 10= Worst pain possible). Higher number is worse outcome while lower number is better outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Return Visit for Same Chief Complaint	1 week	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