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Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

NCT06284434 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-03

No results posted yet for this 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

  • Cleft Lip and Palate

Interventions

DRUG

Liposomal Bupivacaine

Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

DRUG

Bupivacain

Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

DRUG

Epinephrine

Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • Kerry O'Rourke

    lead OTHER

Principal Investigators

  • Chad A. Purnell, MD · Shriners Hospitals for Children

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2026-04-24
Completion
2026-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284434 on ClinicalTrials.gov