Single Shot Exparel vs Catheters in Lower Extremity Trauma

Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture; Fracture Dislocation of Ankle Joint; Fracture Leg; Fracture Femur; Fracture Lower Leg
• Intervention / Treatment: Drug: Exparel + Bupivacaine; Drug: Bupivacaine

Detailed Description

The use of Exparel has been widely criticized over the past few years with regard to its efficacy compared to perineural catheters and whether or not it truly lasts 72 hours, as is often advertised. However, it is still used in many centers for the proposed increased duration of action and ease of use compared to indwelling catheters, which require a greater degree of monitoring and follow-up for removal. Various studies conducted have looked at the efficacy of Exparel and have found no superiority over nerve blocks with other local anesthetic agents. However, nerve blocks with catheters have never been directly compared to exparel injections for pain control. As such, the goal of this study is to elucidate whether there truly is a difference between the two. In this study, the study team will compare preoperative adductor and sciatic nerve blocks with exparel versus catheters in orthopedic surgery patients who present with a traumatic lower extremity injury. Exparel has been documented to increase the duration of a nerve block by up to 72 hours. Studies comparing exparel single shot versus bupivacaine single shot have favored for the latter, which pharmacodynamically makes sense. A liposomal compound which slowly denatures to present an active component would seemingly be unlikely to match up against the higher concentration of said active component flood the desired site of action. In our study, the study team plans to measure the duration of the block with the addition of exparel in comparison to the duration of the block with a catheter which is connected to a pump continuously infusing a set rate of local anesthetics. Our primary research question is whether there is a statistically significant difference in pain control for 72 hours post-op in lower extremity orthopedic trauma when using Exparel versus a short-acting local anesthetic supplied via continuous infusion, in this case ropivacaine.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jevaughn S Davis, MD; Phone Number: 2028234259; Email: jevdavis@mfa.gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Recruiting
      • The George Washington University Hospital
      • Contact: Eduard Shaykhinurov, MS; Phone Number: 202-203-8960; Email: eshaykhinurov@mfa.gwu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine	Drug: 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.
Experimental: Exparel + Bupivacaine	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine equivalents	Morphine equivalents at 24 hours postoperatively	Day 1
Morphine equivalents	Morphine equivalents at 24-48 hours postoperatively	Day 2
Morphine equivalents	Morphine equivalents at 48-72 hours postoperatively	Day 3

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2025
• Primary Completion (Estimated): August 11, 2028
• Study Completion (Estimated): August 11, 2029

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: October 23, 2025
• First Posted (Estimated): October 27, 2025

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: NCR256547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No