EXPAREL® for Pain After Tonsillectomy

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02444533
• Other study ID #: 14-007071
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 8, 2015
• Last updated: May 13, 2015
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy

• Male or female with age = 18 years

• Willing and able to understand and provide written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Tonsillectomy
• Tonsillitis

Intervention

Drug:
• Liposomal Bupivacaine
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score (pain scores on a 0/10 scale)	Patient will record pain scores on a 0/10 scale over a 2 week time frame	2 weeks	No
Primary	Pain medication usage (milligrams used)	Patient will record pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame	2 weeks	No
Primary	Oral intake (patient recorded oral intake)	Patient will record oral intake over one week	1 week	No
Secondary	Patient complication ( 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	Yes
Secondary	Post-tonsillectomy bleeding rate	The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.	4 weeks	Yes