Opioid-Free Study in Arthroscopic Rotator Cuff Repair

February 18, 2020 updated by: Rothman Institute Orthopaedics

Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19148
        • Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing ARCR will be asked to participate in this survey study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Arthroscopic Rotator Cuff Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within first 3 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-operative day 3
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
Post-operative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

December 13, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018LAustin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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