Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures

Study Overview
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Brief Summary
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The purpose of this study is to evaluate two drug options for pain control in patients following wrist injury. Participants will be randomized to one of the 2 pain relief treatments to determine what treatment provides the most effective pain relief

Detailed Description
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The purposes of this noninferiority randomized clinical trial are to determine whether: 1. the most commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 500 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic (hydrocodone 5 mg + acetaminophen 500 mg) in patients with a hand or wrist fracture. 2. the following covariates affect pain outcomes: sex/gender, age, gender-related pain expectations, paid/unpaid work roles, comorbid health status, baseline pain intensity, and employment status.

Official Title
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Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial

Conditions
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Distal Radius Fracture, Pain Management, Metacarpal Fracture

Intervention / Treatment
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* Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab
* Drug: Acetaminophen 500Mg Tab
* Drug: Ibuprofen 600 mg tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients 18 and older undergoing non-operative management of a hand or wrist fracture will be considered eligible. Able to read and speak English Exclusion Criteria: pain exceeding 7/10 on numeric rating scale or 35/50 on PRWE pain scale at enrollment nerve injury surgeon decision that surgery is required history of chronic opioid use documented or suspected substance abuse individuals currently on daily use of ibuprofen, acetaminophen or other pain-altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol) individuals with documented or suspected chronic pain syndrome, reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen history or symptoms of serious medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) patients with active peptic ulcer disease (history of severe heartburn) symptoms of infection pregnant or lactating women diagnosis of cognitive impairment unable to provide informed consent unable or unwilling to fill out the forms prior fracture in same hand on Coumadin or Plavix other medical or psychological health conditions that preclude them from receiving either intervention or unable to return for follow-up visits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants will be randomized to receive either the narcotic hydrocodone with acetaminophen or a combination of acetaminophen plus ibuprofen for post-fracture pain
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narcotic<br>Hydrocodone 5mg/Acetaminophen 500 mg Tab | Drug: Acetaminophen 500Mg Tab<br>* tablet<br>* Other names: tylenol;Drug: Ibuprofen 600 mg tab<br>* tablet<br>* Other names: advil;|
| Experimental: Non Narcotic<br>Ibuprofen 600mg Tab + acetaminophen 500 mg Tab | Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab<br>* tablet<br>* Other names: oxycodone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | PRWE (patient rated wrist evaluation) Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0 | 0-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use | Total medication used will be recorded by a pain diary (for the first 2 weeks) | 2 weeks | 
| Pain diary | participants will be provided a pain diary (for the first 2 weeks) that includes the numeric pain rating scale (NRS), where they can record when they take their medication and the NRS at each self-administration. will use a 0-10 scale where 0 means no pain and 10 is the worst imaginable pain | 2 weeks | 
| Grip strength | Grip strength in kg will be measured with calibrated instrument and standardized test positioning. | 12 weeks | 
| Grip strength | Grip strength in kg will be measured with calibrated instrument and standardized test positioning. | 24 weeks | 
| Pinch strength | pinch strength in kg will be measured with calibrated instrument and standardized test positioning. | 12 weeks | 
| Pinch strength | pinch strength in kg will be measured with calibrated instrument and standardized test positioning. | 24 weeks | 
| Dexterity | dexterity will be tested with a standardized test. dexterity is a timed, in seconds, test. the participant is asked to move small objects from one spot to another. | 12 and 24 weeks | 
| Range of Motion | active range of motion will be measured in degrees with standardized test positioning. | 12 and 24 weeks | 
| pain management | Patient satisfaction with pain management will be measured using a single item satisfaction NRS. using a 0-10 scale where 0 is very unsatisfied and 10 is very satisfied | 3 weeks | 
| Work Impact | Time to return to work will be collected and the Work Limitations Questionnaire will be administered at return to work, 12 and 24 weeks to determine the work impacts of interventions. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time) | 12 and 24 weeks | 
| Future preference | Preference for future pain management. Patients will be asked if they were to have another fracture, would they prefer to have the same or a different pain medication. They will also be asked what medication they thought they were taking so we can assess how this impacts on their preference, and to discern whether patients were aware of their allocation | 24 weeks | 
| Adverse events | Adverse events or complications will be recorded using a standardized complications checklist and a standardized adverse event reporting form completed by their surgeon at each time point | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, RCT