Comparing Exparel and Catheters for Pain After Lower Leg Trauma

This study is comparing two ways to manage pain after surgery for lower leg injuries like ankle, leg, or thigh fractures. One group will receive a single injection of Exparel (a long-acting pain medicine) combined with bupivacaine (another pain medicine). The other group will receive bupivacaine through catheters (small tubes) that deliver medicine continuously. Researchers want to see which method provides better pain control. They will measure your pain levels at 12, 24, and 36 hours after surgery. You may be able to join if you are 18 or older, have a closed lower leg injury, and haven't used opioids before. The study is currently unclear about its recruitment status and plans to enroll 90 participants.

Study design
This interventional study will involve 90 participants. It compares two different pain management approaches for lower extremity trauma.
What's involved
You will receive pain medication before surgery. Your pain levels will be monitored every 12 hours for up to 72 hours after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be monitored for up to 72 hours after the injection.

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NCT07221019

Single Shot Exparel vs Catheters in Lower Extremity Trauma

Recruiting
PHASE4Ages 18+InterventionalSupportive care
George Washington University
~90 participants
Updated 2025-10-28 on ClinicalTrials.gov
What's tested:BupivacaineExparel + Bupivacaine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Postoperative Pain Score
Measured over 12 hours
+5 more outcomes measured
Fracture Dislocation of Ankle Joint
Fracture Leg
Fracture Femur
Fracture Lower Leg
Fracture
1 sites across 1 states
District of Columbia1

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Eligibility criteria

Inclusion

Closed lower extremity orthopedic injury
Opioid naive patients
No other significant surgical injuries on admission as determined by study physician

Exclusion

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
  • Postoperative Pain Score12 hours

    Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

  • Postoperative Pain Score24 hours

    Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

  • Postoperative Pain Score36 hours

    Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

  • Postoperative Pain Score48 hours

    Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

  • Postoperative Pain Score60 hours

    Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

  • Postoperative Pain Score72 hours

    Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)