Recruiting

Exparel vs. Ropivacaine

Sponsor:

George Washington University

Code:

NCT07221019

Conditions

Fracture Dislocation of Ankle Joint

Fracture Leg

Fracture Femur

Fracture Lower Leg

Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

Exparel + Bupivacaine

Study Details

Brief summary:

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.

Conditions

Fracture Dislocation of Ankle Joint

Fracture Leg

Fracture Femur

Fracture Lower Leg

Fracture

Study ID

NCT07221019

Start date

Sep 12, 2025

Status verified date

Oct, 2025

Completion date

Aug 11, 2029

Anticipated

Primary completion date

Aug 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exparel + Bupivacaine

active comparator: Bupivacaine

Interventions

Bupivacaine

Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine with 10 cc of Exparel injected in the adductor space followed by 30 cc of 0.25% bupivacaine with 10 cc of Exparel in the sciatic nerve block. Injections will be completed by an anesthesia provider using astandard aseptic technique with ultrasound guidance. A 22 gauge 5-10cm needle is inserted with direct visualization under ultrasound and 2-5 cc aliquots are injected with aspiration repeated to ensure no vascular injury or injection until a total of 30 cc is injected into the adductor space and 40 cc is injected into the area surrounding the sciatic nerve. Exparel in this situation is being used off-label given that it is not FDA-approved for lower extremity nerve blocks. However, Exparel is commonly used in other nerve blocks and is FDA-approved for blocks such as the interscalene brachial plexus block.

Exparel + Bupivacaine

Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine injected in the adductor space followed by 30 cc of 0.25% bupivacaine in the sciatic nerve block. Injections will be completed by an anesthesia provider in the same manner as above. Catheters will be left in both spaces with post-operative pumps running 0.2% ropivacaine at 8 cc/hr.

Primary outcome measure

  • Postoperative Pain Score [ Time Frame: 12 hours ]
  • Postoperative Pain Score [ Time Frame: 24 hours ]
  • Postoperative Pain Score [ Time Frame: 36 hours ]
  • Postoperative Pain Score [ Time Frame: 48 hours ]
  • Postoperative Pain Score [ Time Frame: 60 hours ]
  • Postoperative Pain Score [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Locations

The George Washington University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

More Information

Sponsor

George Washington University

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2025-10-28.