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

Primary Purpose

Distal Radius Fracture, Pain Management, Metacarpal Fracture

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Hydrocodone 5Mg/Acetaminophen 500Mg Tab
Acetaminophen 500Mg Tab
Ibuprofen 600 mg tab
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring pain management, RCT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Narcotic

Non Narcotic

Arm Description

Hydrocodone 5mg/Acetaminophen 500 mg Tab

Ibuprofen 600mg Tab + acetaminophen 500 mg Tab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Drug use
Total medication used will be recorded by a pain diary (for the first 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
Grip strength
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Grip strength
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Pinch strength
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Pinch strength
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
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.
Range of Motion
active range of motion will be measured in degrees with standardized test positioning.
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
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)
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
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

Full Information

First Posted
September 5, 2017
Last Updated
February 25, 2021
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03375593
Brief Title
Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures
Official Title
Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Pain Management, Metacarpal Fracture
Keywords
pain management, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packs
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Narcotic
Arm Type
Experimental
Arm Description
Hydrocodone 5mg/Acetaminophen 500 mg Tab
Arm Title
Non Narcotic
Arm Type
Experimental
Arm Description
Ibuprofen 600mg Tab + acetaminophen 500 mg Tab
Intervention Type
Drug
Intervention Name(s)
Hydrocodone 5Mg/Acetaminophen 500Mg Tab
Other Intervention Name(s)
oxycodone
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 500Mg Tab
Other Intervention Name(s)
tylenol
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 600 mg tab
Other Intervention Name(s)
advil
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Pain
Description
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
Time Frame
0-2 weeks
Secondary Outcome Measure Information:
Title
Drug use
Description
Total medication used will be recorded by a pain diary (for the first 2 weeks)
Time Frame
2 weeks
Title
Pain diary
Description
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
Time Frame
2 weeks
Title
Grip strength
Description
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Time Frame
12 weeks
Title
Grip strength
Description
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Time Frame
24 weeks
Title
Pinch strength
Description
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Time Frame
12 weeks
Title
Pinch strength
Description
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Time Frame
24 weeks
Title
Dexterity
Description
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.
Time Frame
12 and 24 weeks
Title
Range of Motion
Description
active range of motion will be measured in degrees with standardized test positioning.
Time Frame
12 and 24 weeks
Title
pain management
Description
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
Time Frame
3 weeks
Title
Work Impact
Description
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)
Time Frame
12 and 24 weeks
Title
Future preference
Description
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
Time Frame
24 weeks
Title
Adverse events
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joy C MacDermid, PhD
Phone
519-646-6100
Ext
64636
Email
jmacderm@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Munro, CRA
Phone
519-646-6100
Ext
64640
Email
katrina.munro@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Organizational Affiliation
St. Joseph's Health Care London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only de-identified data will be available upon request

Learn more about this trial

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

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