Actively Recruiting
Single-Shot Exparel Versus Catheters for Pain Control in Lower Extremity Orthopedic Trauma Patients
Led by George Washington University · Updated on 2025-10-28
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pain control effects of a single-shot long-acting local anesthetic called Exparel compared to continuous infusion catheters delivering a short-acting local anesthetic, ropivacaine, in patients undergoing orthopedic surgery for traumatic lower extremity injuries. The study aims to clarify whether Exparel truly provides longer-lasting pain relief up to 72 hours post-operation, as often claimed, by directly comparing it to catheter-based nerve blocks. Participants will receive preoperative adductor and sciatic nerve blocks with either Exparel plus bupivacaine or bupivacaine alone plus catheters delivering continuous ropivacaine infusion through pumps at 8 cc per hour. Injections are administered by anesthesia providers using ultrasound guidance and aseptic techniques. The study includes standard preoperative care with medications like gabapentin, Tylenol, and Toradol or Celebrex. Catheters remain in place postoperatively for continuous local anesthetic delivery in the catheter group. Participants' pain levels will be monitored every 12 hours for up to 72 hours after surgery, and opioid consumption will be tracked daily for three days. The primary measurements focus on postoperative pain scores at set intervals, while secondary outcomes include measuring morphine milligram equivalents on each postoperative day. The study is randomized without masking, and participants will be followed throughout the study duration starting in September 2025 until August 2029.
CONDITIONS
Brief Title
Single Shot Exparel vs Catheters in Lower Extremity Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Closed lower extremity orthopedic injury
- Opioid naive patients
- No other significant surgical injuries on admission as determined by study physician
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours postoperatively
Participants receive either a single-shot Exparel plus bupivacaine nerve block or bupivacaine with catheters delivering ropivacaine for pain control after their lower extremity orthopedic trauma surgery.
1 baseline visit and daily visits for up to 3 days post-surgery
Duration - Up to 3 days after surgery
Participants are monitored for pain control and opioid use after the treatment period ends.
Daily visits for up to 3 days post-surgery
Trial Site Locations
Total: 1 location
1
The George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
J
Jevaughn S Davis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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