Pain ManagementPhase 3NCT07348627
Opioid-Sparing Joint Replacement
A Phase 3 study testing Oxycodone 5 mg and Multimodal Non-Opioid Analgesia in people with Pain Management and Opioid Consumption, run by Emory University at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Opioid Consumption
- What is being tested?
- Oxycodone 5 mg and Multimodal Non-Opioid Analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to Aug 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
- Diagnosis of hip osteoarthritis requiring primary arthroplasty
- Scheduled to undergo anterior total hip arthroplasty (THA)
- Able to comply with study procedures and follow-up visits
- Able to provide informed consent
Who cannot join
- Concurrent significant injuries to other bones or organs
- Local infection at or near the surgical site
- Preoperative opioid use within 4 weeks prior to surgery
- History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction
- Chronic liver disease
- Neurological or psychiatric conditions that may influence pain perception
Show all 14Show fewer
- Pregnancy
- History of alcohol or medication abuse
- Inability to take NSAIDs
- Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily
- Diabetes mellitus with HbA1c > 8.0%
- Diagnosis of chronic pain syndrome or fibromyalgia
- Pain Catastrophizing Scale (PCS) score > 29
- Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Darrell Favors contact
United States1 site, 1 recruiting
- Recruiting
Emory University Orthopedics and Spine Hospital
Atlanta, Georgia, 30329
Ajay Premkumar, MD, 404-778-3350, ajay.premkumar@emory.edu
About this study
Official title: Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial
The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis.
The main questions it aims to answer are:
- Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription?
- Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?
Read the detailed description
This study evaluates whether an opioid-sparing postoperative regimen can reduce opioid use while maintaining effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Although opioids are commonly used after joint replacement, they carry risks such as side effects and long-term dependence. Multimodal analgesic strategies-using combinations of non-opioid medications and local anesthetic techniques-have shown promise in reducing opioid requirements while providing adequate pain relief.
All participants in this randomized, double-blind trial will receive a standardized multimodal non-opioid pain regimen throughout the perioperative period, along with counseling from a Life Care Specialist. Participants will be assigned to receive either a standard opioid prescription or placebo tablets at discharge, with a small supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes will be collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study aims to determine whether limiting routine opioid prescribing after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.
- Conditions
- Pain Management, Opioid Consumption
- Being tested
- Placebo, Oxycodone 5 mg, Multimodal Non-Opioid Analgesia
- Keywords
- Total hip arthroplasty, Numeric Rating Scale for pain, Visual Analog Scale for nausea, Life Care specialist
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
- 28 tablets identical in appearance to 5-mg oxycodone
- Taken 1-2 tablets every 4 hours as needed for moderate to severe pain
- Dispensed by Investigational Drug Services
- Used in combination with standardized multimodal analgesia
Oxycodone 5 mgDrug
- 28 tablets of 5-mg oxycodone
- Taken 1-2 tablets every 4 hours as needed for moderate to severe pain
- Represents standard postoperative prescribing practi
Multimodal Non-Opioid AnalgesiaOther
Multimodal Non-Opioid Analgesia (Standardized Regimen)
Includes:
- Acetaminophen
- Meloxicam
- Methylprednisolone taper
- Spinal anesthesia
- Periarticular local anesthetic injection
- Postoperative scheduled acetaminophen and NSAIDs
- Counseling by Life Care Specialist
- Two 2-mg hydromorphone tablets for rescue only
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Sparing Regimen | Experimental | Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain. Receives: Drug: Placebo; Other: Multimodal Non-Opioid Analgesia |
| Standard Opioid Prescription | Active comparator | Participants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription. Receives: Drug: Oxycodone 5 mg; Other: Multimodal Non-Opioid Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Pain Scores (Numeric Rating Scale, NRS)
A 0-10 numeric scale used to assess pain intensity. Participants rate their pain three times daily during the first postoperative week.
Mean daily pain scores will be compared between groups. High scores: greater pain intensity. Low scores: better pain control.
Measured: Postoperative Days 1-7
Opioid Consumption (Morphine Milligram Equivalents, MME)
Total opioid use, including study medication, rescue hydromorphone, and any additional prescriptions, will be converted to MME to quantify postoperative opioid consumption.
Measured: 1 week, 3 weeks, and 3 months postoperatively
Pain-Related Contacts to Clinical Team
Number of calls or electronic messages to the surgical team related to pain management.
Measured: Up to 3 months postoperatively
Medication-Related Side Effects
Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.
Measured: Postoperative Days 1-7
Opioid Prescription Refills
Number of opioid prescription refills requested or obtained after surgery.
Measured: Up to 3 months postoperatively
Patient Satisfaction With Pain Control
Patient-reported satisfaction with postoperative pain control, rated on a 5-point scale (much worse than expected to much better than expected).
Measured: 1 week, 3 weeks, and 3 months
Secondary outcomes (8)
Patient-Reported Outcomes (PROMs): HOOS Jr
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS Jr.): A validated 6-item questionnaire assessing hip pain and functional ability in patients undergoing hip arthroplasty.
0-100 (converted score)
Interpretation:
- Higher scores indicate better hip function and less pain.
- Lower scores indicate greater disability or worse symptoms.
Measured: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions)
A standardized measure of health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Includes a health VAS.
Index values typically 0-1 High scores: better overall health status. Low scores: poorer health or greater impairment.
Measured: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)
A single-item measure in which patients rate their hip function as a percentage of normal.
- 0% = Completely nonfunctional hip
- 100% = Completely normal hip
Interpretation:
- Higher percentages indicate better perceived hip function.
- Lower percentages indicate worse perceived function.
Measured: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS)
A 13-item questionnaire assessing catastrophic thinking related to pain (rumination, magnification, helplessness). Used at baseline for eligibility.
Score range 0-52 High scores: greater pain catastrophizing; scores >29 indicate high catastrophizing. Low scores: minimal catastrophic thinking.
Measured: Baseline (preoperative) and at 3 months
Postoperative Nausea (VAS-Nausea)
Nausea severity recorded three times daily using a 0-10 Visual Analog Scale. A 0-10 scale used to measure severity of postoperative nausea. Recorded three times daily for 7 days.
High scores: more severe nausea. Low scores: minimal or no nausea.
Measured: Postoperative Days 1-7
Sleep Quality and Pain-Related Satisfaction
A patient-reported measure assessing perceived sleep quality and satisfaction with pain management during the study period.
Both items use a 0-10 Numeric Rating Scale (NRS).
- Higher scores indicate better sleep quality and greater satisfaction with pain management.
- Lower scores indicate poorer sleep quality and lower satisfaction.
Measured: Postoperative Days 1-7
Length of Stay (LOS)
Duration of postoperative hospitalization.
Measured: Day of surgery through discharge (usually upto 7 days)
Healthcare Utilization
Number of emergency department visits, readmissions, and reoperations related to the index surgery.
Measured: Up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start19 Mar 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Premkumar, Emory University
- Investigators
- Ajay Premkumar, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348627
- Sponsor's protocol ID
- 2025P011932
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcomes of the study, including: Daily postoperative pain scores (Numeric Rating Scale, POD 1-7) Opioid consumption data (oral morphine equivalents) at 7 days, 3 weeks, and 3 months Patient-reported outcome measures (HOOS Jr., EQ-5D, Subjective Hip Value) Patient-reported satisfaction with pain control Medication-related side effects (e.g., nausea, constipation) Opioid refill information Length of stay, emergency department visits, readmissions, and reoperations
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07348627
- Acronym / sponsor ID
- 2025P011932
- Conditions
- Pain Management, Opioid Consumption
- Keywords
- Total hip arthroplasty, Numeric Rating Scale for pain, Visual Analog Scale for nausea, Life Care specialist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Jan 2026 (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 clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis.
The main questions it aims to answer are:
- Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription?
- Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?
Detailed description
This study evaluates whether an opioid-sparing postoperative regimen can reduce opioid use while maintaining effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Although opioids are commonly used after joint replacement, they carry risks such as side effects and long-term dependence. Multimodal analgesic strategies-using combinations of non-opioid medications and local anesthetic techniques-have shown promise in reducing opioid requirements while providing adequate pain relief.
All participants in this randomized, double-blind trial will receive a standardized multimodal non-opioid pain regimen throughout the perioperative period, along with counseling from a Life Care Specialist. Participants will be assigned to receive either a standard opioid prescription or placebo tablets at discharge, with a small supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes will be collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study aims to determine whether limiting routine opioid prescribing after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Sparing Regimen | Experimental | Drug: Placebo, Other: Multimodal Non-Opioid AnalgesiaParticipants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain. |
| Standard Opioid Prescription | Active comparator | Drug: Oxycodone 5 mg, Other: Multimodal Non-Opioid AnalgesiaParticipants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of hip osteoarthritis requiring primary arthroplasty
- Scheduled to undergo anterior total hip arthroplasty (THA)
- Able to comply with study procedures and follow-up visits
- Able to provide informed consent
Key exclusion criteria (14 listed)
- Concurrent significant injuries to other bones or organs
- Local infection at or near the surgical site
- Preoperative opioid use within 4 weeks prior to surgery
- History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction
- Chronic liver disease
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 |
|---|---|---|
| Placebo* 28 tablets identical in appearance to 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Dispensed by Investigational Drug Services * Used in combination with standardized multimodal analgesia | Drug | Opioid-Sparing Regimen |
| Oxycodone 5 mg* 28 tablets of 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Represents standard postoperative prescribing practi | Drug | Standard Opioid Prescription |
| Multimodal Non-Opioid AnalgesiaMultimodal Non-Opioid Analgesia (Standardized Regimen) Includes: * Acetaminophen * Meloxicam * Methylprednisolone taper * Spinal anesthesia * Periarticular local anesthetic injection * Postoperative scheduled acetaminophen and NSAIDs * Counseling by Life Care Specialist * Two 2-mg hydromorphone tablets for rescue only | Other | Opioid-Sparing Regimen, Standard Opioid Prescription |
Primary outcome
Daily Pain Scores (Numeric Rating Scale, NRS)
Time frame: Postoperative Days 1-7
A 0-10 numeric scale used to assess pain intensity. Participants rate their pain three times daily during the first postoperative week. Mean daily pain scores will be compared between groups. High scores: greater pain intensity. Low scores: better pain control.
Opioid Consumption (Morphine Milligram Equivalents, MME)
Time frame: 1 week, 3 weeks, and 3 months postoperatively
Total opioid use, including study medication, rescue hydromorphone, and any additional prescriptions, will be converted to MME to quantify postoperative opioid consumption.
Pain-Related Contacts to Clinical Team
Time frame: Up to 3 months postoperatively
Number of calls or electronic messages to the surgical team related to pain management.
Medication-Related Side Effects
Time frame: Postoperative Days 1-7
Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.
Opioid Prescription Refills
Time frame: Up to 3 months postoperatively
Number of opioid prescription refills requested or obtained after surgery.
Patient Satisfaction With Pain Control
Time frame: 1 week, 3 weeks, and 3 months
Patient-reported satisfaction with postoperative pain control, rated on a 5-point scale (much worse than expected to much better than expected).
8 secondary outcomes
Patient-Reported Outcomes (PROMs): HOOS Jr
Time frame: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions)
Time frame: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)
Time frame: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS)
Time frame: Baseline (preoperative) and at 3 months
Postoperative Nausea (VAS-Nausea)
Time frame: Postoperative Days 1-7
Sleep Quality and Pain-Related Satisfaction
Time frame: Postoperative Days 1-7
Length of Stay (LOS)
Time frame: Day of surgery through discharge (usually upto 7 days)
Healthcare Utilization
Time frame: Up to 3 months postoperatively
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 17 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcomes of the study, including: Daily postoperative pain scores (Numeric Rating Scale, POD 1-7) Opioid consumption data (oral morphine equivalents) at 7 days, 3 weeks, and 3 months Patient-reported outcome measures (HOOS Jr., EQ-5D, Subjective Hip Value) Patient-reported satisfaction with pain control Medication-related side effects (e.g., nausea, constipation) Opioid refill information Length of stay, emergency department visits, readmissions, and reoperations
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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.
Darrell Favors contact
Ajay Premkumar, MD principal investigator
Emory University
1 site 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 and Multimodal Non-Opioid Analgesia in people with Pain Management and Opioid Consumption, run by Emory University at 1 site 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 4 inclusion and 14 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 17 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 1 site 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 Ajay Premkumar, MD (404-778-3350, ajay.premkumar@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Pain Scores (Numeric Rating Scale, NRS) (time frame: Postoperative Days 1-7). The study lists 6 primary outcomes in all. 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 17 Apr 2026.