EXPAREL Post-tonsillectomy Clinical Trial

Last updated: May 18, 2021
Sponsor: Paul Hoff
Overall Status: Active - Recruiting

Phase

4

Condition

Ear, Nose, And Throat (Ent) Surgeries

Treatment

N/A

Clinical Study ID

NCT03420638
HSR-17-1714
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Scheduled to undergo bilateral palatine tonsillectomy as the only procedure
  2. Adults age 18 years and older.

Exclusion

Exclusion Criteria:

  1. Severe systemic disease that is clinically significant in the judgement of theinvestigator.
  2. Coagulation disorder that is clinically significant in the judgement of theinvestigator.
  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 theinvestigator.
  7. Cardiovascular disease that is clinically significant in the judgement of theinvestigator.
  8. Impaired liver function that is clinically significant in the judgement of theinvestigator.
  9. Impaired renal function that is clinically significant in the judgement of theinvestigator.
  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 thestudy within the two week follow up.

Study Design

Total Participants: 38
Study Start date:
February 15, 2018
Estimated Completion Date:
December 31, 2021

Study Description

The proposed investigation will examine whether Exparel (bupivacaine liposome injectable suspension 1.3%-13.3 mg/mL) when used as a post-excision adjunct to the standard of care bupivacaine HCl 0.25% (2.5 mg/mL) with Epinephrine (5mcg/mL), will decrease the patient's post-tonsillectomy experience of pain intensity, especially for the first three days after surgery, and correspondingly reduce the requirement for pain medications and improve outcomes.

Connect with a study center

  • St. Joseph Mercy Ann Arbor

    Ann Arbor, Michigan 48106
    United States

    Active - Recruiting

  • Michigan Otolaryngology Surgery Associates

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

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