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Single Shot Exparel vs Catheters in Lower Extremity Trauma

StatusWithdrawn
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: The PI is no longer with the institution, and there is no interest to continue this study by other faculty members.
    • Enrollment target: estimated 90 to confirmed 0
    • Eligibility criteria expanded, about 11 words
    • Site details revised
  2. Primary endpoints revised (6)
    • Study description expanded, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07221019
Lead Sponsor George Washington University
Conditions
(from sponsor)		 Fracture Dislocation of Ankle Joint, Fracture Leg, Fracture Femur, Fracture Lower Leg, Fracture
Related terms Femoral Fractures, Fractures, Bone
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov