NCT06284434 Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
| NCT ID | NCT06284434 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kerry O'Rourke |
| Condition | Cleft Lip and Palate |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2026-04-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2024-04-24 with a primary completion date of 2026-04-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at: * pain scores at hip and jaw sites * opioid use in amount and frequency * scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.
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.
Contact & Investigator
Chad A. Purnell, MD
PRINCIPAL INVESTIGATOR
Shriners Hospitals for Children
Frequently Asked Questions
Who can join the NCT06284434 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Cleft Lip and Palate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06284434 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06284434 currently recruiting?
Yes, NCT06284434 is actively recruiting participants. Contact the research team at cpurnell@shrinenet.org for enrollment information.
Where is the NCT06284434 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06284434 clinical trial?
NCT06284434 is sponsored by Kerry O'Rourke. The principal investigator is Chad A. Purnell, MD at Shriners Hospitals for Children. The trial plans to enroll 60 participants.