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

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

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Sprains and Strains; Trauma; Acute Pain; Sprains; Injuries; Acute Musculoskeletal Disease
• Intervention / Treatment: Drug: Ibuprofen; Drug: Lidocaine Patch 4%

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Vidant Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ibuprofen; Ibuprofen 800mg every 8 hours for 3 days	Drug: Ibuprofen; Ibuprofen tablet; Other Names: Advil; Motrin
Experimental: Ibuprofen & 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	Drug: Ibuprofen; Ibuprofen tablet; Other Names: Advil; Motrin; Drug: Lidocaine Patch 4%; Lidocaine patch; Other Names: Lidocaine Pain Relief Patch

What is the study measuring?

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 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.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a 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

Collaborators and Investigators

• Sponsor: East Carolina University
• Investigators: Study Director: Jennifer Stahl, MD, East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2018
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: June 17, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: acute pain; injury; emergency department; muscle strain; muscle sprain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Muscular Diseases; Emergencies; Acute Pain; Musculoskeletal Pain; Sprains and Strains; Musculoskeletal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ibuprofen
• Other Study ID Numbers: UMCIRB 17-001594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No