Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07221019

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

Clinical and Radiological Outcomes of Medacta Shoulder Syste...

Primary Osteoarthritis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here