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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Postoperative Days 1-7 |
| Opioid Prescription Refills | Number of opioid prescription refills requested or obtained after surgery. | 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). | 1 week, 3 weeks, and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Premkumar, MD | Contact | 404-778-3350 | ajay.premkumar@emory.edu | |
| Darrell Favors | Contact | darrell.favors@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ajay Premkumar, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Orthopedics and Spine Hospital | Recruiting | Atlanta | Georgia | 30329 | United States |
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
Data will become available after publication of the primary study results and will remain available for up to 5 years following publication, contingent upon institutional data retention policies.
De-identified data will be shared with qualified researchers whose proposed use of the data has been approved by the study investigators.
Requests for data access must be submitted to the corresponding author. Approved requests will be granted through a secure data-sharing mechanism (e.g., encrypted file transfer or institutional data-sharing platform) following execution of a data use agreement, as required.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Oxycodone 5 mg | Drug |
|
|
| Multimodal Non-Opioid Analgesia | Other | Multimodal Non-Opioid Analgesia (Standardized Regimen) Includes:
|
|
| 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. | 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.
Interpretation:
| 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. | 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. | 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).
| Postoperative Days 1-7 |
| Length of Stay (LOS) | Duration of postoperative hospitalization. | Day of surgery through discharge (usually upto 7 days) |
| Healthcare Utilization | Number of emergency department visits, readmissions, and reoperations related to the index surgery. | Up to 3 months postoperatively |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |