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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2025-09-12 with a primary completion date of 2028-08-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07221019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fracture Dislocation of Ankle Joint. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221019 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07221019 currently recruiting?
Yes, NCT07221019 is actively recruiting participants. Contact the research team at jevdavis@mfa.gwu.edu for enrollment information.
Where is the NCT07221019 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT07221019 clinical trial?
NCT07221019 is sponsored by George Washington University. The trial plans to enroll 90 participants.