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Multimodal Opioid-Free Orthopaedic Procedures
NCT04659317Phase 3
Key facts
- Status
- Recruiting
- Start
- Dec 2020
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Small Molecules
- Drugs
- oxycodone
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, double-blind trial of oxycodone in postoperative pain (2 arms), sponsored by Emory University. Primary endpoint: Visual Analog Scale for Pain at 60 months. Started Dec 2020; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Opioid Group
Participants receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery.
Placebo Group
Participants receive encapsulated placebo tablets x24, to take po q6 hours as needed for pain after surgery.
03
Who it enrols
Adult patients undergoing primary total joint replacement for advanced arthritis or other specified orthopaedic procedures, who have exhausted 3+ months of nonoperative treatment, excluding those with recent opioid use, uncontrolled diabetes, or significant comorbidities.
04
Endpoints
Primary
Visual Analog Scale for Pain
Secondary
Patient Satisfaction Scores
Opioid consumption
Associated side effects
Single Assessment Numeric Evaluation
American Shoulder and Elbow Surgeons Index Scale
European Quality of Life 5 dimension
Length of stay postoperative
Number of complications
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