PainPhase 3NCT04659317
Opioid-Free Orthopaedics
A Phase 3 study testing Oxycodone 5 mg Oral Tablet in people with Pain and Pain, Postoperative, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain, Postoperative
- What is being tested?
- Oxycodone 5 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2020to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Emory Clinic
Atlanta, Georgia, 30024
Eric Wagner, MD, eric.r.wagner@emory.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Eric Wagner, MD, eric.r.wagner@emory.edu
- Recruiting
Emory Orthopedic and Spine Hospital
Tucker, Georgia, 30084
Eric Wagner, MD, eric.r.wagner@emory.edu
About this study
Official title: A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures
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.
Read the 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
- Being tested
- Oxycodone 5 mg Oral Tablet, Placebo oral tablet
- Keywords
- Pain management, Oxycodone
- Medical subject headings
- Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 5 mg Oral TabletDrug
Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
Placebo oral tabletDrug
Encapsulated placebo tablets x24, to take po q6 hours as need for pain
| Study group | Role | What they receive |
|---|---|---|
| Opioid Group | Active comparator | 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 Receives: Drug: Oxycodone 5 mg Oral Tablet |
| Placebo Group | Experimental | 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 Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain (VAS) Score
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
Measured: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Secondary outcomes (8)
Change in patient Satisfaction Scores
Patients will be asked their overall level of satisfaction with the procedure and pain control.
The investigators will use a rating scale with the following choices:
- I'm doing MUCH WORSE than I expected
- I'm doing SOMEWHAT WORSE than I expected
- I'm doing ABOUT THE SAME as I expected
- I'm doing SOMEWHAT BETTER than I expected
- I'm doing MUCH BETTER than I expected
- It is too soon for me to give an opinion
The scale has a maximum value of a patient stating they are doing much better than expected (5) and much worse as the minimum value (1) quantifying the worst outcome. Patients stating it is too soon to give an opinion is a null value.
Measured: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Change in opioid consumption
The investigators will assess the amount of opioids consumed utilizing total morphine equivalents as an equal metric to compare between patients. It will also de assessed whether the patient utilized he safety/rescue prescription. It will also be included the information on whether patients obtain a refill prescription. Total consumption will be assessed by utilizing total morphine equivalents as the metric as stated previously with patients with higher values quantifying a worse outcome.
Measured: Baseline, 60 months post operative
Change in associated side effects
The investigators will utilize a 0-10 scale for patient symptoms for feeling any of these side effects due to postoperative medication for the first 14 days and at each follow up visit. We will assess only at each subsequent follow up visit 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months so long as they are continuously taking medications associated with postoperative pain protocol. Outcomes with a score of 10 will quantify a poor result and patients dealing with severe common side effects due to opioid medication.
Measured: Postoperatively for the first 14 days, and then 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Change in Single Assessment Numeric Evaluation (SANE) score
The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. The patient will be asked this question at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. A rating of 0 is the minimum value and denotes the lowest possible value and worse outcome a patient can have on the scale.
Measured: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
The ASES is a survey designed to assess the condition of the shoulder. This survey will only be utilized in the cases of patients with a shoulder pathology. The survey will utilize the 10 components assessing the activities of daily living. Scores range from 0 to 100 with a score of 0 denoting a worse shoulder condition. The investigators will utilize this assessment at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months.
Measured: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Change in European Quality of Life 5 dimension (EQ-5D)
The EQ-5D is one of the most commonly used assessments for measuring health and quality of life. The EQ-5D will be assessed at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. The assessment utilizes a scale of 0 to 1 with a score of 0 corresponding to death and 1 representing perfect health.
Measured: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Length of stay postoperative
The investigators will assess length of stay as another outcome for surgery types that typically require admission to the hospital. It will be assessed this once and collect data with regards to hospital stay following their discharge from the hospital. A shorter time interval corresponds to a better outcome and those patients with a longer stay is a less desirable outcome.
Measured: End of the trial (up to 60 months post operative)
Number of complications
The investigators will assess complications due to surgery such as reoperation, readmission, revision procedure, temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent pain, fractures, and implant loosening and dislocations. The assessment of these complications will happen as they occur and will be recorded as a descriptive and no true values will be recorded rather than the complication itself.
Measured: End of the trial (up to 60 months post operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start11 Dec 2020
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Wagner, Emory University
- Investigators
- Eric Wagner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659317
- Sponsor's protocol ID
- STUDY00000478
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures
- ClinicalTrials.gov ID
- NCT04659317
- Acronym / sponsor ID
- STUDY00000478
- Conditions
- Pain, Pain, Postoperative
- Keywords
- Pain management, Oxycodone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Group | Active comparator | Drug: Oxycodone 5 mg Oral TabletParticipants 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 |
| Placebo Group | Experimental | Drug: Placebo oral tabletParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone 5 mg Oral TabletEncapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed | Drug | Opioid Group |
| Placebo oral tabletEncapsulated placebo tablets x24, to take po q6 hours as need for pain | Drug | Placebo Group |
Primary outcome
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
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
8 secondary outcomes
Change in patient Satisfaction Scores
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
Change in opioid consumption
Time frame: Baseline, 60 months post operative
Change in associated side effects
Time frame: Postoperatively for the first 14 days, and then 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Change in Single Assessment Numeric Evaluation (SANE) score
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
Time frame: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Change in European Quality of Life 5 dimension (EQ-5D)
Time frame: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Length of stay postoperative
Time frame: End of the trial (up to 60 months post operative)
Number of complications
Time frame: End of the trial (up to 60 months post operative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Wagner, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxycodone 5 mg Oral Tablet in people with Pain and Pain, Postoperative, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Dawes (404-784-2402, adawes@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.