EXPAREL Post-tonsillectomy Clinical Trial

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Tonsillectomy is one of the most commonly performed surgical procedures in the United States. The primary indications for tonsillectomy in the adult population include recurrent pharyngitis, chronic tonsillitis, and obstructive pathology. Tonsillectomy is often associated with severe postoperative pain, which can result in prolonged poor oral intake, dehydration, and the need for high dose narcotics. In severely dehydrated patients, epithelial shedding and necrosis of soft tissues at the surgical site can lead to postoperative complications such as bleeding, delayed healing, and severe pain. The goal for this study is to explore the use of a long acting local anesthetic bupivacaine liposome injectable suspension (Exparel) to manage pain experienced by adult patients after tonsillectomy

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul Hoff
• Collaborator: St. Joseph Mercy Ann Arbor
• Treatments: Bupivacaine; Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

1. Scheduled to undergo bilateral palatine tonsillectomy as the only procedure

2. Adults age 18 years and older.

Exclusion Criteria:

1. Severe systemic disease that is clinically significant in the judgement of the investigator.

2. Coagulation disorder that is clinically significant in the judgement of the investigator.

3. Current or previous history of analgesic dependence

4. Allergy to any of the drugs used in the study (bupivacaine)

5. Women known to be pregnant, planning to become pregnant, or lactating

6. Hearing impairment that is clinically significant in the judgement of the investigator.

7. Cardiovascular disease that is clinically significant in the judgement of the investigator.

8. Impaired liver function that is clinically significant in the judgement of the investigator.

9. Impaired renal function that is clinically significant in the judgement of the investigator.

10. Unable to provide consent.

11. Additional surgical procedures planned concurrently with palatine tonsillectomy.

12. Planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.