EXPAREL® for Pain After Tonsillectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients

Conditions
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Tonsillectomy, Tonsillitis, Post-operative Pain

Intervention / Treatment
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* Drug: Liposomal Bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal Bupivacaine<br>Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy | Drug: Liposomal Bupivacaine<br>* Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.<br>* Other names: Exparel;|
| No Intervention: No treatment<br>Patient will not be given any medications in the tonsillar fossae after tonsillectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score (Pain Scores on a 0/10 Scale) | 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 | day of surgery, 14 days after surgery | 
| Pain Medication Usage (Milligrams Used) | Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame | 2 weeks after surgery | 
| Oral Intake (Patient Recorded Oral Intake) | Subjects recorded oral intake over one week after surgery | 1 week after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposomal Bupivacaine