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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 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.

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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

Cleft Lip and Palate

Interventions

  • DRUG Liposomal Bupivacaine
  • DRUG Bupivacain
  • DRUG Epinephrine

Study Locations (1)

Illinois

  • Shriners Children's Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-04-24
Est. Completion 2026-04-24
Phase Phase 3

Sponsor

Kerry O'Rourke

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06284434

The ClinicalTrials.gov registry entry for NCT06284434 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (72% lower). The listed sponsor is Kerry O'Rourke, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.