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NCT06284434 · ClinicalTrials.gov registry record · Phase 3
Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
A Phase 3 study of Cleft Lip and Palate, sponsored by Kerry O'Rourke.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06284434: Recruiting Phase 3 study of Cleft Lip and Palate, sponsored by Kerry O'Rourke.
NCT06284434 is a Phase 3 study of Cleft Lip and Palate that is actively recruiting participants, run by Kerry O'Rourke. The registered enrollment target is 60 participants, below the 212-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06284434, a Phase 3 study of Cleft Lip and Palate, is actively recruiting participants, sponsored by Kerry O'Rourke.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Liposomal Bupivacaine
- DRUG Bupivacain
- DRUG Epinephrine
Study Locations (1)
Illinois
- Shriners Children's Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2026-04-24 |
| Phase | Phase 3 |
What NCT06284434 shows while recruiting
NCT06284434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 212-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Cleft Lip and Palate appearing as the primary indexed condition, and to 3 interventions - of which Liposomal Bupivacaine is the first listed.
NCT06284434 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06284434 about?
NCT06284434 is a clinical study titled "Liposomal Bupivacaine Use in Alveolar Bone Graft Patients". 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...
What is the current status of trial NCT06284434?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2024-04-24. Estimated completion is 2026-04-24.
What conditions does trial NCT06284434 study?
This clinical trial studies the following conditions: Cleft Lip and Palate.
What interventions are being tested in trial NCT06284434?
The interventions under investigation include: Liposomal Bupivacaine (DRUG), Bupivacain (DRUG), Epinephrine (DRUG).
Who is sponsoring clinical trial NCT06284434?
This trial is sponsored by Kerry O'Rourke, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06284434 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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