Tonsillitis Clinical Trials

Find Tonsillitis Clinical Trials Near You

Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults

Who is this study for? Adults scheduled to undergo bilateral palatine tonsillectomy
What treatments are being studied? Exparel
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Scheduled to undergo bilateral palatine tonsillectomy as the only procedure

• Adults age 18 years and older.

Locations
United States
Michigan
St. Joseph Mercy Ann Arbor
RECRUITING
Ann Arbor
Michigan Otolaryngology Surgery Associates
RECRUITING
Ypsilanti
Contact Information
Primary
Paul T Hoff, MD
Paul.Hoff@stjoeshealth.org
734-712-7509
Time Frame
Start Date: 2018-02-15
Estimated Completion Date: 2021-12-31
Participants
Target number of participants: 38
Treatments
Experimental: Adjunct Exparel
After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side. Following the standard medication, the principal investigator will infiltrate 0.5 mL of adjunct Exparel (bupivacaine liposome suspension 1.3% \[13.3 mg/mL\], i.m.) into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine liposome injectable suspension on each side.
Other: Standard Care
After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/ mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side.
Authors
Joanne [Juan] Wu, Paul T Hoff
Related Therapeutic Areas
Sponsors
Collaborators: St. Joseph Mercy Ann Arbor
Leads: Paul Hoff

This content was sourced from clinicaltrials.gov