NCT02444533

EXPAREL® for Pain After Tonsillectomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tonsillectomy
• Tonsillitis
• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Liposomal Bupivacaine	Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-05-14
• Last updated: 2017-07-14
• Results posted: 2017-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study