Can we ditch opioids after surgery? new trial aims to find out
NCT ID NCT04659317
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a standard opioid painkiller (oxycodone) to a placebo in people recovering from orthopedic surgery like joint replacements. The goal is to see if a non-opioid pain management plan can control pain just as well. About 80 adults having various orthopedic procedures will rate their pain and satisfaction over several months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Oxycodone 5 mg oral tablet and placebo oral tablet
- What this could lead to
- If successful, this could show that opioid-free pain control is effective after orthopedic surgery, reducing reliance on opioids.
- What could go wrong
- This is a small, early-phase trial with only 80 participants, so results may not apply to everyone. The non-opioid regimen might not control pain as well as opioids for some patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Orthopedic and Spine Hospital
RECRUITINGTucker, Georgia, 30084, United States
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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The Emory Clinic
RECRUITINGAtlanta, Georgia, 30024, United States
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