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Completed

NCT Number: NCT04277208

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.

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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

  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 outcomes

  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

Interested in participating?

Completed

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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.

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