Exparel vs Catheters for Broken Leg
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Nerve Block
Participants receive preoperative adductor and sciatic nerve blocks with either Exparel or catheters
Postoperative Monitoring
Participants' pain and opioid consumption are monitored for up to 72 hours after injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Exparel
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Washington University
Lead Sponsor