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Opioid-Free Study in Arthroscopic Rotator Cuff Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 5, 2019
First Posted Date February 20, 2020
Last Update Posted Date February 20, 2020
Actual Study Start Date June 13, 2018
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 18, 2020)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Opioid-Free Study in Arthroscopic Rotator Cuff Repair
Official Title Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergoing ARCR will be asked to participate in this survey study
Condition Rotator Cuff Tears
Intervention Not Provided
Study Groups/Cohorts Arthroscopic Rotator Cuff Repair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2020)
36
Original Actual Enrollment Same as current
Actual Study Completion Date July 1, 2019
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04277208
Other Study ID Numbers 2018LAustin
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date February 2020