Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
Recruiting
Phase 3
Interventional Study
Cleft Lip and Palate
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 60 (estimated)
- Sponsor
- Kerry O'Rourke · Other
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About This Trial
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 …
Trial Locations
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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 wit…
Contacts