Recruiting
Phase 3

Liposomal Bupivacaine

Sponsor:

Kerry O'Rourke

Code:

NCT06284434

Conditions

Cleft Lip and Palate

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Liposomal Bupivacaine

Bupivacain

Epinephrine

Study Details

Brief 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

Study ID

NCT06284434

Start date

Apr 24, 2024

Status verified date

Jul, 2024

Completion date

Apr 24, 2026

Anticipated

Primary completion date

Apr 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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 with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).
  • Patients with a history of cardiovascular disease.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: LB Treatment Arm

Patients on the treatment arm will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000), which is not considered the standard of care.

active comparator: Bupivacaine Control Arm

Patients on the control arm will follow the current standard of care, which is traditional bupivacaine mixed with epinephrine (1:100,000).

Interventions

Liposomal Bupivacaine

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

Bupivacain

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

Epinephrine

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

Primary outcome measure

  • Visual Analog Pain Scores [ Time Frame: on Day 1 to Day 5 after surgery ]
  • Opioid Use [ Time Frame: on Day 1 to Day 5 after surgery ]
  • PROMIS Pediatric Mobility Questionnaire [ Time Frame: on Day 1 to Day 5 after surgery ]

Central Contacts and Locations

Central contacts

Chad A. Purnell, MD

(724)-433-1645cpurnell@shrinenet.org

Benjamin M. Smith, MS

(773) 385-5865BenjaminM.Smith@shrinenet.org

Locations

Shriners Children's Chicago

Recruiting

Chicago, Illinois, United States, 60707

Contacts

Benjamin M Smith, MS

773-385-5865benjaminm.smith@shrinenet.org

Principal Investigator:

Chad A Purnell, MD

More Information

Sponsor

Kerry O'Rourke

Last update posted

Jul 3, 2024

Last verified

Jul, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kerry O'Rourke on 2024-07-03.