Opioid-Free Study in Arthroscopic Rotator Cuff Repair

Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04277208

Enrollment

Registered

2020-02-20

Start date

2018-06-13

Completion date

2019-07-01

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results