Opioid-Free Study in Arthroscopic Rotator Cuff Repair
Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial
1 other identifier
observational
36
1 country
1
Brief Summary
The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedFebruary 20, 2020
February 1, 2020
6 months
August 5, 2019
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to fulfill oxycodone prescription
data collected to the time from surgery until the patient chooses to fulfill a prescription for opioid medication following surgery
within first 3 days of surgery
Secondary Outcomes (2)
VAS pain (Visual Analog Scale)
Post-operative day 3
Patient satisfaction
Post-operative day 3
Study Arms (1)
Arthroscopic Rotator Cuff Repair
Eligibility Criteria
patients undergoing ARCR will be asked to participate in this survey study
You may qualify if:
- All patients over the age of 18
- clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR)
You may not qualify if:
- Patients with irreparable rotator cuff tears
- allergic or sensitivity to the study medication
- intolerance to pain protocol
- history of gastrointestinal issues
- renal disease
- any evidence of glenohumeral arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Institute
Philadelphia, Pennsylvania, 19148, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2019
First Posted
February 20, 2020
Study Start
June 13, 2018
Primary Completion
December 13, 2018
Study Completion
July 1, 2019
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share