רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT07348627 עבור ניהול כאב, צריכת אופיואידים הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
אוניברסיטת אמוריOpioid-Sparing Joint Replacement שלב III 120
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07348627 מתוכנן לבדוק את טיפול עבור ניהול כאב, צריכת אופיואידים. זהו מחקר שלב III מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 בפברואר 2026, במטרה לכלול 120 משתתפים. המחקר ינוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 באוגוסט 2028. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-16 בינואר 2026.
סיכום קצר
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...
תיאור מפורט
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 anes...הצג עוד
כותרת רשמית
Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial
מצבים רפואיים
ניהול כאבצריכת אופיואידיםמזהי מחקר נוספים
- 2025P011932
מספר NCT
תחילת המחקר (בפועל)
2026-02
עדכון אחרון שפורסם
2026-01-16
סיום המחקר (מוערך)
2028-08
משתתפים (מתוכנן)
120
סוג המחקר
התערבותי
שלב
שלב III
סטטוס
טרם החל גיוס
מילות מפתח
Total hip arthroplasty
Numeric Rating Scale for pain
Visual Analog Scale for nausea
Life Care specialist
Numeric Rating Scale for pain
Visual Analog Scale for nausea
Life Care specialist
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
משולש
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיOpioid-Sparing Regimen 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. | פלצבו * 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 Multimodal Non-Opioid Analgesia 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 |
משווה פעילStandard Opioid Prescription 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. | 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 Multimodal Non-Opioid Analgesia 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 |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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. | 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.
* 0% = Completely nonfunctional hip
* 100% = Completely normal hip
Interpretation:
* Higher percentages indicate better perceived hip function.
* Lower percentages indicate worse perceived function. | 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).
* Higher scores indicate better sleep quality and greater satisfaction with pain management.
* Lower scores indicate poorer sleep quality and lower satisfaction. | 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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- 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
- 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
אוניברסיטת אמוריהגורם האחראי למחקר
Ajay Premkumar, חוקר ראשי, Assistant Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Ajay Premkumar, MD, 404-778-3350, [email protected]
איש קשר: Darrell Favors, [email protected]
1 מיקומי המחקר ב-1 מדינות
Georgia
Emory University Orthopedics and Spine Hospital, Atlanta, Georgia, 30329, United States
Ajay Premkumar, MD, איש קשר, 404-778-3350, [email protected]