Single Shot Exparel vs Catheters in Lower Extremity Trauma

NCT07221019 | Recruiting Phase 4 FDA Drug

• 1 other identifier: NCR256547
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Postoperative Pain Score

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

  12 hours

• Postoperative Pain Score

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

  24 hours

• Postoperative Pain Score

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

  36 hours

• Postoperative Pain Score

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

  48 hours

• Postoperative Pain Score

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

  60 hours

• Postoperative Pain Score

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

  72 hours

Secondary Outcomes (3)

• Morphine equivalents

  Day 1

• Morphine equivalents

  Day 2

• Morphine equivalents

  Day 3

Study Arms (2)

Exparel + Bupivacaine

EXPERIMENTAL

Drug: Exparel + Bupivacaine

Bupivacaine

ACTIVE COMPARATOR

Drug: Bupivacaine

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.

Bupivacaine

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.

Exparel + Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University Hospital

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

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Fractures, Bone

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Jevaughn S Davis, MD

CONTACT

2028234259; jevdavis@mfa.gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): August 11, 2028
• Study Completion (Estimated): August 11, 2029
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)