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Liposomal Bupivacaine for Pain After Cleft Lip and Palate Surgery

This study is looking at whether a pain medication called liposomal bupivacaine (brand name EXPAREL®) works better than the standard pain medication, bupivacaine, for children and teens who have had surgery for cleft lip and palate. Both medications will be mixed with epinephrine. Researchers want to see if liposomal bupivacaine helps control pain more effectively, allows patients to be more active, and reduces the need for opioid pain medicines after surgery. You may be able to join if you are 6 years or older, have cleft lip and/or palate, and are scheduled for an alveolar bone graft surgery. The study will compare pain scores, how much opioid medicine is used, and activity levels between the two groups. The study is currently recruiting patients.

Study design
This is a randomized, double-blinded study, meaning participants are randomly assigned to receive one of the two treatments, and neither you nor your doctors will know which one you are receiving. Up to 60 patients will participate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain, opioid use, and mobility will be monitored for 5 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06284434

Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

UNKNOWN
PHASE3Ages 6+InterventionalSupportive care
Kerry O'Rourke
~60 participants
Updated 2024-07-03 on ClinicalTrials.gov
What's tested:Liposomal BupivacaineBupivacainEpinephrine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analog Pain Scores
Measured over on Day 1 to Day 5 after surgery
+2 more outcomes measured

Conditions

Cleft Lip and Palate

Explore related trials

Alveolar bone graftCleft palate with cleft lip

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

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

Who to contact

Chad A. Purnell, MD
[email protected]
(724)-433-1645
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Visual Analog Pain Scoreson Day 1 to Day 5 after surgery

    Pain scores at hip and jaw sites. Pain is rated on a 0 to 10 scale with 0 representing no pain and 10 representing agonizing pain with unbearable distress. A lower score is ideal for improved pain management.

  • Opioid Useon Day 1 to Day 5 after surgery

    Opioid use in amount and frequency

  • PROMIS Pediatric Mobility Questionnaireon Day 1 to Day 5 after surgery

    The patient will log activity level using the Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Mobility scale. The categorical answers to the questions are the minimum value "not able to do", "with a lot of trouble", "with some trouble", "with a little trouble", and the maximum value "with no trouble." Therefore a higher amount of reported with no trouble categorical answers would represent improved mobility.