Back to resultsThe Effect of Patient Education on Opioid Consumption
Primary Purpose
Rotator Cuff Injury
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Formal education regarding opioid usage
Sponsored by
About this trial
This is an interventional health services research trial for Rotator Cuff Injury
Eligibility Criteria
Inclusion Criteria:
- Over the age of 18
- clinically indicated for an arthroscopic rotator cuff repair
Exclusion Criteria:
- Patients with irreparable rotator cuff tears
- allergic or sensitivity to the study medication
- history of gastrointestinal issues
- any evidence of glenohumeral arthritis
- inability to consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Normal pre-operative education
Opioid usage education
Arm Description
• Control group received normal pre-operative education regarding surgery
• The study group received formal education detailing recommended post-operative opioid usage, side effects, dependence, and addiction
Outcomes
Primary Outcome Measures
Opioid Usage
count of total narcotic pills not taken by patients
Secondary Outcome Measures
Full Information
NCT ID
NCT03105791
First Posted
April 4, 2017
Last Updated
April 4, 2017
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03105791
Brief Title
The Effect of Patient Education on Opioid Consumption
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal pre-operative education
Arm Type
No Intervention
Arm Description
• Control group received normal pre-operative education regarding surgery
Arm Title
Opioid usage education
Arm Type
Active Comparator
Arm Description
• The study group received formal education detailing recommended post-operative opioid usage, side effects, dependence, and addiction
Intervention Type
Other
Intervention Name(s)
Formal education regarding opioid usage
Intervention Description
Participannts watched a 2 minute video and were given educational materials
Primary Outcome Measure Information:
Title
Opioid Usage
Description
count of total narcotic pills not taken by patients
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over the age of 18
clinically indicated for an arthroscopic rotator cuff repair
Exclusion Criteria:
Patients with irreparable rotator cuff tears
allergic or sensitivity to the study medication
history of gastrointestinal issues
any evidence of glenohumeral arthritis
inability to consent
12. IPD Sharing Statement
Learn more about this trial
The Effect of Patient Education on Opioid Consumption
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