90 Participants Needed

Exparel vs Catheters for Broken Leg

JS
Overseen ByJevaughn S Davis, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: George Washington University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best pain relief method for individuals undergoing orthopedic surgery for a broken leg. Researchers will compare Exparel, a long-acting painkiller, with catheters delivering the short-acting ropivacaine. They seek to determine which method better controls pain and reduces the need for additional pain medications over 72 hours. Ideal participants have a closed leg injury and have not previously used opioids. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, with the goal of understanding its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should be opioid naive, meaning they should not have used opioids before.

What is the safety track record for these treatments?

Research has shown that Exparel, when combined with bupivacaine, is generally well-tolerated. One study found that this combination provides effective pain relief for up to 72 hours after surgery, potentially reducing the need for opioids, which are strong painkillers with possible side effects. Another study involving children over 6 years old demonstrated that Exparel and bupivacaine together were safe and effective for pain management. While some studies report varying results, overall evidence supports the safety of using Exparel with bupivacaine for managing pain in surgical patients.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Exparel for treating broken legs because it offers a new way to manage pain. Unlike traditional options like catheters that continuously deliver anesthesia, Exparel is a long-acting version of bupivacaine, which is delivered directly to the surgical site in a single dose. This can provide prolonged pain relief, potentially reducing the need for additional pain medication. By combining Exparel with bupivacaine, there's the potential for even greater pain control, which could improve patient comfort and recovery times.

What evidence suggests that this trial's treatments could be effective for managing pain in patients with broken legs?

Studies have shown that Exparel, a long-lasting pain reliever, can effectively manage post-surgical pain. In one review, patients who underwent surgery for broken bones and received Exparel reported good pain control and required fewer opioids. Another study found that Exparel provided better pain relief than regular bupivacaine after knee replacement surgery. In this trial, one group of participants will receive Exparel combined with bupivacaine, while another group will receive bupivacaine alone. This suggests that combining Exparel with bupivacaine might effectively manage pain for surgeries involving broken bones.16789

Are You a Good Fit for This Trial?

This trial is for individuals with lower extremity trauma such as hip, spine, ankle fractures or broken legs. Participants must be scheduled for orthopedic surgery and receive nerve blocks before the operation. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have a healed bone injury in my leg.
I don't have major surgical injuries according to the study doctor.
Opioid naive patients

Exclusion Criteria

Chronic opioid use
Patient has intraoperative cardiac arrest
I need plastic surgery to fully close a wound.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Nerve Block

Participants receive preoperative adductor and sciatic nerve blocks with either Exparel or catheters

1 day
1 visit (in-person)

Postoperative Monitoring

Participants' pain and opioid consumption are monitored for up to 72 hours after injection

3 days
Monitoring every 12 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Exparel
Trial Overview The study tests single-shot Exparel against catheters delivering ropivacaine in patients undergoing surgery for traumatic leg injuries. Pain levels and opioid use will be monitored every 12 hours up to three days post-injection.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel + BupivacaineExperimental Treatment1 Intervention
Group II: BupivacaineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

Citations

Randomized Controlled Trial for Exparel Hip FractureThis is a prospective, randomized study looking at the effect that a long-acting local anesthetic has on pain control in patients having surgery for hip ...
The use of liposomal bupivacaine in fracture surgery: a reviewThis systematic review of the available data identified a total of eight studies evaluating the use of liposomal bupivacaine in patients with fractures.
The Use of Exparel (Liposomal Bupivacaine) to Manage ...Inpatient pain control was the primary outcome. Secondary outcome measures included ROM (extension and flexion), nausea and vomiting, narcotic consumption, ...
Exparel Versus Bupivacaine: Outcomes, Advantages, And Costs(2017) conducted a Level I systemic review and meta-analysis comparing bupivacaine to liposomal bupivacaine in terms of safety and efficacy following TKA.
EXPARELefficacy results for each dose and selecting a single ... Combined administration with bupivacaine HCl is described in the EXPAREL.
NCT07212114 | Efficacy of EXPAREL vs. BupivacaineThe objective is to determine whether the EXPAREL-based regimen provides more effective and longer-lasting analgesia compared to bupivacaine ...
Efficacy of Liposomal Bupivacaine and ...This study found that liposomal bupivacaine did not improve postoperative recovery or pain compared with bupivacaine hydrochloride alone among patients ...
Safety and Efficacy of Long-Acting Liposomal Bupivacaine ...This study evaluates the tolerability and efficacy of preoperative dorsal penile nerve block with Exparel plus bupivacaine hydrochloride in children>6 years old
Bupivacaine Liposome (Exparel) - Medical Clinical Policy ...The authors concluded that bupivacaine extended-release demonstrated a statistically significant reduction in pain through 72 hours, decreased opioid ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security