Clinical trial NCT02444533: EXPAREL® for Pain After Tonsillectomy
Official title: A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillectomy
Tonsillitis
Post-operative Pain
Keywords: Liposomal Bupivacaine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain Score (Pain Scores on a 0/10 Scale)
timeFrame: day of surgery, 14 days after surgery
measure: Pain Medication Usage (Milligrams Used)
timeFrame: 2 weeks after surgery
measure: Oral Intake (Patient Recorded Oral Intake)
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)
timeFrame: 4 weeks
measure: Number of Subjects With Post-tonsillectomy Bleeding
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Daniel L Price, MD
role: PRINCIPAL_INVESTIGATOR
References: