Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Launched by KERRY O'ROURKE · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a pain medication called liposomal bupivacaine (EXPAREL®) to see if it can better manage pain after alveolar bone graft surgery in patients aged 6 and older with cleft lip and palate. The researchers want to find out if this new medication can help patients feel less pain, allow them to be more active, and reduce the need for stronger painkillers (opioids) compared to the standard treatment. They will measure pain at the surgery sites, how much and how often patients use opioids, and look at how active they feel after the surgery.

To participate in the study, patients must be 6 years or older and scheduled for an alveolar bone graft surgery due to cleft lip and/or palate. However, younger children, those with allergies to the study medications, or individuals with heart problems cannot join. Participants can expect to have their pain and activity levels tracked during the study, and their experiences will be compared to those receiving the usual treatment. This trial aims to improve pain management for patients undergoing this type of surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients that are 6 and older who have a diagnosis of cleft lip and/or palate with a scheduled surgery that involves an alveolar bone graft.
• Exclusion Criteria:
• • Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.
• • Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).
• • Patients with a history of cardiovascular disease.