Opioid-Free Study in Arthroscopic Rotator Cuff Repair

The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Time to fulfill oxycodone prescription

Time frame: 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 outcomes

VAS pain (Visual Analog Scale)

Time frame: 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

Time frame: Post-operative day 3

Patient will be asked on a 5 point likert scale to rate their satisfaction with their post-operative pain regime

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Feb 20, 2020
Registry last updated: Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed