Using liposomal bupivacaine for pain management in patients with cleft lip and palate undergoing surgery
Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
This study is testing if a new pain management option using liposomal bupivacaine can help kids and teens with cleft lip and palate feel less pain after their surgery compared to the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Shriners Hospitals for Children Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06284434 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of liposomal bupivacaine (EXPAREL®) with epinephrine in managing post-operative pain for patients aged 6 and older who have undergone alveolar bone graft surgery due to cleft lip and palate. The study is a randomized, double-blinded trial comparing this treatment to the standard bupivacaine with epinephrine. Researchers will assess pain scores, opioid usage, and activity levels over the first five days post-surgery. A total of 60 patients will be enrolled at Shriners Children's Chicago over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 and older diagnosed with cleft lip and/or palate scheduled for alveolar bone graft surgery.
Not a fit: Patients under the age of 6 or those with a history of allergic reactions to the study drugs will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain control and reduced opioid use in pediatric patients after surgery.
How similar studies have performed: Previous studies have indicated that liposomal bupivacaine can provide better pain control compared to standard treatments, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- Shriners Children's Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Chad A. Purnell, MD — Shriners Hospitals for Children
- Study coordinator: Chad A. Purnell, MD
- Email: cpurnell@shrinenet.org
- Phone: (724)-433-1645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.