EXPAREL® for Pain After Tonsillectomy
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|ClinicalTrials.gov Identifier: NCT02444533|
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tonsillectomy Tonsillitis Post-operative Pain||Drug: Liposomal Bupivacaine||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Liposomal Bupivacaine
Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Drug: Liposomal Bupivacaine
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Other Name: Exparel
No Intervention: No treatment
Patient will not be given any medications in the tonsillar fossae after tonsillectomy
- Pain Score (Pain Scores on a 0/10 Scale) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 1 week after surgery ]Subjects recorded oral intake over one week after surgery
- Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) [ Time Frame: 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 [ Time Frame: 4 weeks ]The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444533
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Daniel L Price, MD||Mayo Clinic|