NCT04659317

Opioid-Free Orthopaedics

A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

Detailed description

Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Conditions

• Pain
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Oxycodone 5 mg Oral Tablet	Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
DRUG	Placebo oral tablet	Encapsulated placebo tablets x24, to take po q6 hours as need for pain

Timeline

• Start date: 2020-12-11
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2020-12-09
• Last updated: 2025-04-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study