RECRUITING

Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Quick Facts

Study Start:2024-04-24
Study Completion:2026-04-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06284434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.
  2. * Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).
  3. * Patients with a history of cardiovascular disease.

Contacts and Locations

Study Contact

Chad A. Purnell, MD
CONTACT
(724)-433-1645
cpurnell@shrinenet.org
Benjamin M. Smith, MS
CONTACT
(773) 385-5865
BenjaminM.Smith@shrinenet.org

Principal Investigator

Chad A. Purnell, MD
PRINCIPAL_INVESTIGATOR
Shriners Hospitals for Children

Study Locations (Sites)

Shriners Children's Chicago
Chicago, Illinois, 60707
United States

Collaborators and Investigators

Sponsor: Kerry O'Rourke

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24
Study Completion Date2026-04-24

Study Record Updates

Study Start Date2024-04-24
Study Completion Date2026-04-24

Terms related to this study

Keywords Provided by Researchers

  • cleft lip
  • cleft palate
  • alveolar bone graft
  • pain management
  • liposomal bupivacaine

Additional Relevant MeSH Terms

  • Cleft Lip and Palate