NCT07221019 Single Shot Exparel vs Catheters in Lower Extremity Trauma
| NCT ID | NCT07221019 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | George Washington University |
| Condition | Fracture Dislocation of Ankle Joint |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2028-08-11 |
Trial Parameters
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Brief Summary
This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.
Eligibility Criteria
Inclusion Criteria: * Closed lower extremity orthopedic injury * Opioid naive patients * No other significant surgical injuries on admission as determined by study physician Exclusion Criteria: * Allergy to local anesthetics * Multiple traumatic injuries * Weight less than 60 kg * Prior opioid use or risk of increased pain control needs as determined by PI * Chronic opioid use * Open fractures * Plastic surgery needed for complete closure * Patient has intraoperative cardiac arrest