EXPAREL® for Pain After Tonsillectomy

Phase 4

Completed

Brief 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.

Detailed Description: Subjects will be screened in the clinic when being evaluated for indications for tonsillectomy. Once the decision to proceed with tonsillectomy is made, the patient will be given the information on the study, provided time to review the information and interested patients will be consented.

There will be two stages in the study. The first will be the operative stage, which includes the injection during the operation. The second stage is the patient participation stage. During this stage, the patient records the amount of oral pain medication usage, oral intake after their procedure, in addition to their pain scores. These scores are recorded and brought back (or mailed in) to the clinic for collection during the follow up visit, approximately 1 month later (patients will keep records for two weeks). The patients will be freed from participation in the study after the one month visit.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal Bupivacaine	Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy

Primary Outcome Measures

Name	Time	Method
Pain Score (Pain Scores on a 0/10 Scale)	day of surgery, 14 days after surgery	Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated "no pain" and 10 indicated "worst possible pain"
Pain Medication Usage (Milligrams Used)	2 weeks after surgery	Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame
Oral Intake (Patient Recorded Oral Intake)	1 week after surgery	Subjects recorded oral intake over one week after surgery

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)	4 weeks	Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.
Number of Subjects With Post-tonsillectomy Bleeding	4 weeks	The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.