Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
Primary Purpose
Acute Musculoskeletal Disease, Sprains, Sprains and Strains
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Lidocaine Patch 4%
Sponsored by
About this trial
This is an interventional treatment trial for Acute Musculoskeletal Disease focused on measuring acute pain, muscle strain, muscle sprain, injury, emergency department
Eligibility 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
Sites / Locations
- Vidant Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ibuprofen
Ibuprofen & Lidocaine Patch 4%
Arm Description
Ibuprofen 800mg every 8 hours for 3 days
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
Outcomes
Primary Outcome Measures
Change in Numerical Pain Rating Scale
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
Questionnaire (Yes or No) of 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03571737
Brief Title
Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
Official Title
Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 23, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
January 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 moreso than the antiinflammatory-only regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Musculoskeletal Disease, Sprains, Sprains and Strains, Injuries, Emergencies, Trauma, Acute Pain
Keywords
acute pain, muscle strain, muscle sprain, injury, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 800mg every 8 hours for 3 days
Arm Title
Ibuprofen & Lidocaine Patch 4%
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin, Advil
Intervention Description
Ibuprofen tablet
Intervention Type
Drug
Intervention Name(s)
Lidocaine Patch 4%
Other Intervention Name(s)
Lidocare Pain Relief Patch
Intervention Description
Lidocaine patch
Primary Outcome Measure Information:
Title
Change in Numerical Pain Rating Scale
Description
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).
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Questionnaire (Yes or No) of Return Visit for Same Chief Complaint
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunjeong Lee, MD
Phone
8179057387
Email
leehyu16@ecu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Mainhart, BSCLR, CCRP
Phone
2527445568
Email
farmera@ecu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunjeong Lee, MD
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Mainhart
First Name & Middle Initial & Last Name & Degree
Hyunjeong Lee, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
We'll reach out to this number within 24 hrs