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Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

ConditionCleft Lip and Palate
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6+
SponsorKerry O'Rourke

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal Bupivacaine

    Drug

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

  • Bupivacain

    Drug

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

  • Epinephrine

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: LB Treatment ArmExperimental treatment 2 interventions
Group B: Bupivacaine Control ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Visual Analog Pain Scores

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.

Time frame
on Day 1 to Day 5 after surgery
2

Opioid Use

Opioid use in amount and frequency

Time frame
on Day 1 to Day 5 after surgery
3

PROMIS Pediatric Mobility Questionnaire

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.

Time frame
on Day 1 to Day 5 after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kerry O'Rourke

Lead sponsor

Shriners Hospitals for Children

Sponsor institution

Shriners Hospitals for Children

Collaborator

Source ClinicalTrials.gov
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