Opioid-Free Orthopaedics

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04659317
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Pain
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 11, 2020
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Opioid Group
    Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
  • Experimental: Placebo Group
    Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain

Primary Outcome Measure

Change in Pain (VAS) Score [ Time Frame: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Eric Wagner, MD
[email protected]
The Emory ClinicAtlantaGeorgia30024
Eric Wagner, MD
[email protected]
Emory Orthopedic and Spine HospitalTuckerGeorgia30084
Eric Wagner, MD
[email protected]

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GAThe Emory Clinic· Atlanta, GAEmory Orthopedic and Spine Hospital· Tucker, GA

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