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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%

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

NCT ID

NCT03571737

First Posted

June 2, 2018

Last Updated

July 3, 2018

Sponsor

East Carolina University

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

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

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

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

leehyu16@ecu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Allison Mainhart, BSCLR, CCRP

Phone

2527445568

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

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

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