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NCT04277208 Clinical Trial

Opioid-Free Study in Arthroscopic Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Official title:
Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04277208
Other study ID # 2018LAustin
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2018
Est. completion date July 1, 2019

Study information
Verified date February 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 1, 2019
Est. primary completion date December 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Rothman Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to fulfill oxycodone prescription 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 VAS pain (Visual Analog Scale) 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
Secondary Patient satisfaction Patient will be asked on a 5 point likert scale to rate their satisfaction with their post-operative pain regime Post-operative day 3
See also
  Status Clinical Trial Phase
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Recruiting NCT06055478 - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair N/A
Completed NCT04552925 - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears N/A
Not yet recruiting NCT06032416 - DenCT Shoulder Bone Quality Evaluation N/A
Not yet recruiting NCT04047745 - Post-operative Exparel Study Following Rotator Cuff Repair N/A
Completed NCT01029574 - Platelet Rich Plasma on Rotator Cuff Repair Phase 3
Not yet recruiting NCT05817578 - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Suspended NCT04421417 - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing N/A
Recruiting NCT06156423 - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery N/A
Completed NCT06145815 - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting NCT05009498 - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery N/A
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A