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Opioid-Free Study in Arthroscopic Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT04277208
Recruitment Status : Completed
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Rotator Cuff Tears

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : July 1, 2019

Group/Cohort
Arthroscopic Rotator Cuff Repair



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing ARCR will be asked to participate in this survey study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277208


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04277208    
Other Study ID Numbers: 2018LAustin
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries