Single-shot Exparel versus continuous nerve catheters for lower-extremity trauma
Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients
PHASE4 · George Washington University · NCT07221019
This trial will test whether a one-time Exparel plus bupivacaine injection provides similar pain control to continuous ropivacaine catheters for patients receiving preoperative adductor and sciatic nerve blocks for traumatic lower-leg fractures, with pain checked every 12 hours for 72 hours and opioid use tracked.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | George Washington University (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT07221019 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional trial compares single-shot liposomal bupivacaine (Exparel) plus bupivacaine to perineural catheters delivering continuous ropivacaine in patients undergoing orthopedic surgery for closed traumatic lower-extremity fractures who receive preoperative adductor and sciatic nerve blocks. Pain scores will be recorded every 12 hours for up to 72 hours after the nerve block and opioid consumption will be converted to morphine milligram equivalents and tracked over the same period. Key inclusion criteria include opioid-naive adults with closed lower-extremity injuries and weight ≥60 kg, while exclusions include open fractures, multiple traumatic injuries, chronic opioid use, and allergy to local anesthetics. The trial is conducted at The George Washington University Hospital and compares duration and intensity of analgesia and opioid requirements between the two approaches.
Who should consider this trial
Good fit: Adults with closed traumatic lower-extremity fractures who are opioid-naive, weigh at least 60 kg, have no other major injuries, and are planned to receive preoperative adductor and sciatic nerve blocks are ideal candidates.
Not a fit: Patients with open fractures, multiple traumatic injuries, chronic opioid use, allergy to local anesthetics, those needing plastic surgery for closure, or those unable to attend follow-up at the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could offer longer-lasting pain relief without the monitoring and maintenance required for indwelling catheters and might reduce opioid use after surgery.
How similar studies have performed: Previous comparisons of Exparel single-shot to single-shot bupivacaine have not shown clear superiority for Exparel, and direct comparisons against continuous perineural catheters have been lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- The George Washington University Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Jevaughn S Davis, MD
- Email: jevdavis@mfa.gwu.edu
- Phone: 2028234259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fracture Dislocation of Ankle Joint, Fracture Leg, Fracture Femur, Fracture Lower Leg, Fracture