Single Shot Exparel vs Catheters in Lower Extremity Trauma

Not Applicable

Recruiting

• Conditions: Fracture Dislocation of Ankle Joint; Fracture Leg; Fracture Femur; Fracture Lower Leg; Fracture
• Interventions: Drug: Exparel + Bupivacaine; Drug: Bupivacaine

• Registration Number: NCT07221019
• Lead Sponsor: George Washington University

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.

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 Timeline

• Study Start: 2025-09-12
• Status Verified: 2025-10
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-23
• Last Update Submitted: 2025-10-24
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-28
• Primary Completion: 2028-08-11
• Study Completion: 2029-08-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exparel + Bupivacaine	Exparel + Bupivacaine	-
Bupivacaine	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Score	72 hours	Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

Secondary Outcome Measures

Name	Time	Method
Morphine equivalents	Day 3	Morphine equivalents at 48-72 hours postoperatively

Trial Locations

Locations (1)

The George Washington University Hospital; 🇺🇸 Washington D.C., District of Columbia, United States