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

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ClinicalTrials.gov Identifier: NCT03571737
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hyunjeong Lee, 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.

Condition or disease Intervention/treatment Phase
Acute Musculoskeletal Disease Sprains Sprains and Strains Injuries Emergencies Trauma Acute Pain Drug: Ibuprofen Drug: Lidocaine Patch 4% Phase 3

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 moreso than the antiinflammatory-only regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department: A Prospective Randomized Controlled Study
Actual Study Start Date : June 23, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen
Ibuprofen 800mg every 8 hours for 3 days
Drug: Ibuprofen
Ibuprofen tablet
Other Names:
  • Motrin
  • Advil

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:
  • Motrin
  • Advil

Drug: Lidocaine Patch 4%
Lidocaine patch
Other Name: Lidocare Pain Relief Patch




Primary Outcome Measures :
  1. Change in Numerical Pain Rating Scale [ Time Frame: 72 hours ]
    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).


Secondary Outcome Measures :
  1. Questionnaire (Yes or No) of Return Visit for Same Chief Complaint [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571737


Contacts
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Contact: Hyunjeong Lee, MD 8179057387 leehyu16@ecu.edu
Contact: Allison Mainhart, BSCLR, CCRP 2527445568 farmera@ecu.edu

Locations
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United States, North Carolina
Vidant Medical Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Allison Mainhart         
Principal Investigator: Hyunjeong Lee, MD         
Sponsors and Collaborators
East Carolina University
Investigators
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Principal Investigator: Hyunjeong Lee, MD East Carolina University

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Responsible Party: Hyunjeong Lee, Principal Investigator, East Carolina University
ClinicalTrials.gov Identifier: NCT03571737     History of Changes
Other Study ID Numbers: UMCIRB 17-001594
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyunjeong Lee, East Carolina University:
acute pain
muscle strain
muscle sprain
injury
emergency department
Additional relevant MeSH terms:
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Sprains and Strains
Musculoskeletal Pain
Emergencies
Acute Pain
Musculoskeletal Diseases
Disease Attributes
Pathologic Processes
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Ibuprofen
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents