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

NCT03571737 | Completed Phase 3 Results FDA Drug

• 1 other identifier: UMCIRB 17-001594
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Musculoskeletal Disease; Sprains; Sprains and Strains; Injuries; Emergencies; Trauma; Acute Pain

Keywords

acute pain; muscle strain; muscle sprain; injury; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With a Return Visit for Same Chief Complaint

  1 week

Study Arms (2)

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 800mg every 8 hours for 3 days

Drug: Ibuprofen

Ibuprofen & Lidocaine Patch 4%

EXPERIMENTAL

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; Drug: Lidocaine Patch 4%

Interventions

Ibuprofen DRUG

Ibuprofen tablet

Also known as: Motrin, Advil

Ibuprofen; Ibuprofen & Lidocaine Patch 4%

Lidocaine Patch 4% DRUG

Lidocaine patch

Also known as: Lidocaine Pain Relief Patch

Ibuprofen & Lidocaine Patch 4%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Sprains and Strains; Wounds and Injuries; Emergencies; Acute Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Jennifer Stahl
• Organization: Brody School of Medicine @ East Carolina University

stahlj@ecu.edu

2527442570

Study Officials

• Jennifer Stahl, MD

  East Carolina University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: June 28, 2018
• Study Start: June 23, 2018
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2021
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2024-03

Locations

US (1)