EXPAREL® for Pain After Tonsillectomy

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether liposomal bupivacaine (long acting injectable anesthetic) provides greater post operative pain relief compared to the standard post operative pain regiment for tonsillectomy patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy

• Willing and able to understand and provide written informed consent

Exclusion Criteria:

• Known pregnancy

• Women who are currently nursing a child

• History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder

• Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation

• Inability to provide informed consent (patients under guardianship)

• Known hypersensitivity to local anesthetics

• History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.

• History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.

• Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.

• History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.