Recruiting
Phase 3

Multimodal Regimen

Sponsor:

Emory University

Code:

NCT04659317

Conditions

Pain

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxycodone 5 mg Oral Tablet

Placebo oral tablet

Study Details

Brief 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.

Conditions

Pain

Pain, Postoperative

Study ID

NCT04659317

Start date

Dec 11, 2020

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
  • Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
  • Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
  • Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
  • Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent

Exclusion Criteria:

  • Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
  • Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
  • Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Oxycodone 5 mg Oral Tablet

Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed

Placebo oral tablet

Encapsulated placebo tablets x24, to take po q6 hours as need 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 and Locations

Central contacts

Alexander Dawes

404-784-2402adawes@emory.edu

Locations

The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30024

Contacts

Eric Wagner, MD

eric.r.wagner@emory.edu

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Eric Wagner, MD

eric.r.wagner@emory.edu

Emory Orthopedic and Spine Hospital

Recruiting

Tucker, Georgia, United States, 30084

Contacts

Eric Wagner, MD

eric.r.wagner@emory.edu

More Information

Sponsor

Emory University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Pain management
  • Oxycodone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-30.