Opioid-Free Study in Arthroscopic Rotator Cuff Repair

Completed

• Conditions: Rotator Cuff Tears

• Registration Number: NCT04277208
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-13
• Primary Completion: 2018-12-13
• Study Completion: 2019-07-01
• Study First Submitted: 2019-08-05
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• All patients over the age of 18
• clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to fulfill oxycodone prescription	within first 3 days of surgery	data collected to the time from surgery until the patient chooses to fulfill a prescription for opioid medication following surgery

Secondary Outcome Measures

Name	Time	Method
VAS pain (Visual Analog Scale)	Post-operative day 3	patient-reported pain as measured on a scale from 0-10. Zero means no pain and 10 being worst pain imaginable
Patient satisfaction	Post-operative day 3	Patient will be asked on a 5 point likert scale to rate their satisfaction with their post-operative pain regime

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States