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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
39
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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"
Time frame: 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
Time frame: 2 weeks after surgery
Oral Intake (Patient Recorded Oral Intake)
Subjects recorded oral intake over one week after surgery
Time frame: 1 week after surgery
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.
Time frame: 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.
Time frame: 4 weeks
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