EXPAREL® (bupivacaine liposome injectable suspension)
PK and Safety of EXPAREL for Postoperative Analgesia in Pediatric Patients Undergoing Cardiac Surgery
Summary1
Condition: Postsurgical analgesia for participants undergoing cardiac surgery
Treatment: EXPAREL® (bupivacaine liposome injectable suspension), bupivacaine HCl
Male & Female
Age Range: 0–5 years
5 Locations
Phase 1
What is this study about?
- This study is exploring ways to manage pain in young children after heart surgery. EXPAREL, a long-acting form of the local anesthetic bupivacaine, may help reduce pain for a longer period after surgery compared to standard bupivacaine. Researchers want to understand how EXPAREL moves through the body (pharmacokinetics) and how safe it is for children under 6 years old who are undergoing cardiac surgery. By studying this, doctors hope to improve pain relief and recovery for children after heart surgery1
What treatment is being studied?
- The treatment being studied is EXPAREL, a non-opioid medicine that helps manage pain after surgery
- How it works: EXPAREL slowly releases bupivacaine, a local anesthetic, over time to help control pain for up to several days after surgery
- How it’s given: It is injected directly into the area around the surgical site (a method called local infiltration analgesia), where it numbs the nerves to help reduce pain1
- The study compares EXPAREL with bupivacaine hydrochloride (HCl), the standard short-acting version of the same medicine1
What will happen during the study?
- This study will take place in three parts; each part will include children from different age groups (2–6 years, 6 months–2 years, and newborn–6 months)1
- In each part, children will be randomly assigned to receive either EXPAREL or standard bupivacaine HCI during surgery1
- Doctors will carefully monitor how the medicine is processed in the body and watch for any side effects1
- The information gathered from older children will help guide safe dosing for younger children as the study progresses1
How can I learn more?
If you’d like to learn more about this study or find out whether your child may be eligible to participate, talk to your child’s healthcare provider, reach out to the study team at your local research center, or contact sarah.shaffer@pacira.com.
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