[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07348627":3,"trial-entities:NCT07348627":154,"trial-summary:NCT07348627":158},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":49,"secondary_outcomes":72,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":125,"locations":128,"central_contacts":144,"overall_officials":149,"references":152,"see_also_links":153},"NCT07348627","2025P011932","Opioid-Sparing Joint Replacement","Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial","RECRUITING","2028-08","2026-04","2026-04-17","2026-03-19","Emory University","OTHER",true,"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.\n\nThe main questions it aims to answer are:\n\n* Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription?\n* Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?","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.\n\nAll 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.",[19,20],"Pain Management","Opioid Consumption",[22,23,24,25],"Total hip arthroplasty","Numeric Rating Scale for pain","Visual Analog Scale for nausea","Life Care specialist","INTERVENTIONAL","TREATMENT",[29],"PHASE3",{"count":31,"type":32},120,"ESTIMATED",[34,40,45],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Placebo","* 28 tablets identical in appearance to 5-mg oxycodone\n* Taken 1-2 tablets every 4 hours as needed for moderate to severe pain\n* Dispensed by Investigational Drug Services\n* Used in combination with standardized multimodal analgesia",[39],"Opioid-Sparing Regimen",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Oxycodone 5 mg","* 28 tablets of 5-mg oxycodone\n* Taken 1-2 tablets every 4 hours as needed for moderate to severe pain\n* Represents standard postoperative prescribing practi",[44],"Standard Opioid Prescription",{"type":14,"name":46,"description":47,"armGroupLabels":48},"Multimodal Non-Opioid Analgesia","Multimodal Non-Opioid Analgesia (Standardized Regimen)\n\nIncludes:\n\n* Acetaminophen\n* Meloxicam\n* Methylprednisolone taper\n* Spinal anesthesia\n* Periarticular local anesthetic injection\n* Postoperative scheduled acetaminophen and NSAIDs\n* Counseling by Life Care Specialist\n* Two 2-mg hydromorphone tablets for rescue only",[39,44],[50,54,58,62,65,68],{"measure":51,"description":52,"timeFrame":53},"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.\n\nMean daily pain scores will be compared between groups. High scores: greater pain intensity. Low scores: better pain control.","Postoperative Days 1-7",{"measure":55,"description":56,"timeFrame":57},"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",{"measure":59,"description":60,"timeFrame":61},"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",{"measure":63,"description":64,"timeFrame":53},"Medication-Related Side Effects","Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.",{"measure":66,"description":67,"timeFrame":61},"Opioid Prescription Refills","Number of opioid prescription refills requested or obtained after surgery.",{"measure":69,"description":70,"timeFrame":71},"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",[73,77,80,83,86,89,92,96],{"measure":74,"description":75,"timeFrame":76},"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.\n\n0-100 (converted score)\n\nInterpretation:\n\n* Higher scores indicate better hip function and less pain.\n* Lower scores indicate greater disability or worse symptoms.","Baseline (preoperative) and at 3 months",{"measure":78,"description":79,"timeFrame":76},"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\u002Fdiscomfort, and anxiety\u002Fdepression. Includes a health VAS.\n\nIndex values typically 0-1 High scores: better overall health status. Low scores: poorer health or greater impairment.",{"measure":81,"description":82,"timeFrame":76},"Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)","A single-item measure in which patients rate their hip function as a percentage of normal.\n\n* 0% = Completely nonfunctional hip\n* 100% = Completely normal hip\n\nInterpretation:\n\n* Higher percentages indicate better perceived hip function.\n* Lower percentages indicate worse perceived function.",{"measure":84,"description":85,"timeFrame":76},"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.\n\nScore range 0-52 High scores: greater pain catastrophizing; scores \\>29 indicate high catastrophizing. Low scores: minimal catastrophic thinking.",{"measure":87,"description":88,"timeFrame":53},"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.\n\nHigh scores: more severe nausea. Low scores: minimal or no nausea.",{"measure":90,"description":91,"timeFrame":53},"Sleep Quality and Pain-Related Satisfaction","A patient-reported measure assessing perceived sleep quality and satisfaction with pain management during the study period.\n\nBoth items use a 0-10 Numeric Rating Scale (NRS).\n\n* Higher scores indicate better sleep quality and greater satisfaction with pain management.\n* Lower scores indicate poorer sleep quality and lower satisfaction.",{"measure":93,"description":94,"timeFrame":95},"Length of Stay (LOS)","Duration of postoperative hospitalization.","Day of surgery through discharge (usually upto 7 days)",{"measure":97,"description":98,"timeFrame":61},"Healthcare Utilization","Number of emergency department visits, readmissions, and reoperations related to the index surgery.","ALL","18 Years",null,false,{"inclusion":104,"exclusion":109,"raw_text":124},[105,106,107,108],"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",[110,111,112,113,114,115,116,117,118,119,120,121,122,123],"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","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","Inclusion Criteria:\n\n* Diagnosis of hip osteoarthritis requiring primary arthroplasty\n* Scheduled to undergo anterior total hip arthroplasty (THA)\n* Able to comply with study procedures and follow-up visits\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Concurrent significant injuries to other bones or organs\n* Local infection at or near the surgical site\n* Preoperative opioid use within 4 weeks prior to surgery\n* History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction\n* Chronic liver disease\n* Neurological or psychiatric conditions that may influence pain perception\n* Pregnancy\n* History of alcohol or medication abuse\n* Inability to take NSAIDs\n* Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily\n* Diabetes mellitus with HbA1c \\> 8.0%\n* Diagnosis of chronic pain syndrome or fibromyalgia\n* Pain Catastrophizing Scale (PCS) score \\> 29\n* Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up",[126,127],"ADULT","OLDER_ADULT",[129],{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":134,"contacts":135,"geoPoint":141},"Emory University Orthopedics and Spine Hospital","Atlanta","Georgia","30329","United States",[136],{"name":137,"role":138,"phone":139,"email":140},"Ajay Premkumar, MD","CONTACT","404-778-3350","ajay.premkumar@emory.edu",{"lat":142,"lon":143},33.749,-84.38798,[145,146],{"name":137,"role":138,"phone":139,"email":140},{"name":147,"role":138,"email":148},"Darrell Favors","darrell.favors@emory.edu",[150],{"name":137,"affiliation":13,"role":151},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":155,"biomarkers":157},[156],"Osteoarthritis",[],{"nct_id":4,"found":15,"summary":159,"prompt_version":169},{"design":160,"status":161,"heading":162,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This is a randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctors will know which treatment you are receiving. It plans to enroll 120 participants.","completed","Opioid-Sparing Joint Replacement Study","This study is looking at whether a pain management plan that uses fewer opioids (pain medications like oxycodone) can still effectively control pain after total hip replacement surgery for osteoarthritis. All participants will receive a standard non-opioid pain regimen, including medications like acetaminophen and meloxicam, along with spinal anesthesia and local anesthetic injections. Some participants will also receive 5 mg oxycodone tablets, while others will receive identical-looking placebo tablets. The researchers want to see if limiting routine opioid prescriptions can reduce how much opioid medication you use without making your pain worse or affecting your satisfaction. You might be able to join if you are an adult having total hip replacement surgery for hip osteoarthritis and can follow study procedures. The study will measure your daily pain, how much opioid medication you use, and how often you contact your care team about pain for up to three months after surgery. The current recruitment status is unclear.","Participants will be followed for up to 3 months after surgery to assess pain-related contacts to the clinical team.",156,"You will receive a standardized pain regimen and counseling. Your pain scores, nausea, opioid use, and other outcomes will be collected during the first week after surgery and at follow-up visits at 3 weeks and 3 months.","Not stated in the trial record.",[36],"v2"]