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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571737
• Other study ID #: UMCIRB 17-001594
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: March 2024
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Musculoskeletal Disease
• Acute Pain
• Emergencies
• Injuries
• Musculoskeletal Diseases
• Musculoskeletal Pain
• Sprains
• Sprains and Strains
• Trauma

Intervention

Drug:
• Ibuprofen
Ibuprofen tablet
• Lidocaine Patch 4%
Lidocaine patch

Locations

Country	Name	City	State
United States	Vidant Medical Center	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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