Single Shot Exparel vs Catheters in Lower Extremity Trauma

Conditions

• Fracture
• Fracture Dislocation of Ankle Joint
• Fracture Femur
• Fracture Leg
• Fracture Lower Leg

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bupivacaine — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Sep 12, 2025

Status verified

Oct 2025

Primary completion

Aug 11, 2028

Completion

Aug 11, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Exparel + Bupivacaine
• Active Comparator: Bupivacaine

Primary Outcome Measure

Postoperative Pain Score [ Time Frame: 12 hours ]

Central Contacts

• Jevaughn S Davis, MD
  2028234259
  [email protected]

Locations (1)

Find similar trials in Washington D.C., DC

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