Status:
UNKNOWN
EXPAREL Post-tonsillectomy Clinical Trial
Lead Sponsor:
Paul Hoff
Collaborating Sponsors:
St. Joseph Mercy Ann Arbor
Conditions:
Tonsillectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Detailed 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% ...
Eligibility Criteria
Inclusion
- Scheduled to undergo bilateral palatine tonsillectomy as the only procedure
- Adults age 18 years and older.
Exclusion
- Severe systemic disease that is clinically significant in the judgement of the investigator.
- Coagulation disorder that is clinically significant in the judgement of the investigator.
- Current or previous history of analgesic dependence
- Allergy to any of the drugs used in the study (bupivacaine)
- Women known to be pregnant, planning to become pregnant, or lactating
- Hearing impairment that is clinically significant in the judgement of the investigator.
- Cardiovascular disease that is clinically significant in the judgement of the investigator.
- Impaired liver function that is clinically significant in the judgement of the investigator.
- Impaired renal function that is clinically significant in the judgement of the investigator.
- Unable to provide consent.
- Additional surgical procedures planned concurrently with palatine tonsillectomy.
- Planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03420638
Start Date
February 15 2018
End Date
December 31 2021
Last Update
May 19 2021
Active Locations (2)
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1
St. Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States, 48106
2
Michigan Otolaryngology Surgery Associates
Ypsilanti, Michigan, United States, 48197