Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Kerry O'Rourke
Study ID
NCT06284434
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cleft Lip and Palate

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 24, 2024
Status verified
Jul 2024
Primary completion
Apr 24, 2026
Completion
Apr 24, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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).

Primary Outcome Measure

Visual Analog Pain Scores [ Time Frame: on Day 1 to Day 5 after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shriners Children's ChicagoChicagoIllinois60707
Benjamin M Smith, MS
[email protected]
773-385-5865
Chad A Purnell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Shriners Children's Chicago· Chicago, IL

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