Single Shot Exparel vs Catheters in Lower Extremity Trauma

George Washington University (GW)

Status and phase: Enrolling; Phase 4

Conditions: Fracture Dislocation of Ankle Joint; Fracture Lower Leg; Fracture; Fracture Femur; Fracture Leg

Treatments: Drug: Bupivacaine; Drug: Exparel + Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07221019

NCR256547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Exparel + Bupivacaine

Experimental group

Treatment:

Drug: Exparel + Bupivacaine

Bupivacaine

Active Comparator group

Treatment:

Drug: Bupivacaine