EXPAREL Post-tonsillectomy Clinical Trial

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Paul Hoff
Study ID
NCT03420638
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Tonsillectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adjunct Exparel (bupivacaine liposome suspension 1.3%) — DRUG
    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 1.3% (13.3 mg/mL) on each side.
  • Standard Care — OTHER
    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.

Study Details

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

Key Dates

First listed
Feb 5, 2018
Start date
Feb 15, 2018
Status verified
May 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days [ Time Frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
St. Joseph Mercy Ann ArborAnn ArborMichigan48106
Paul T Hoff, MD
[email protected]
734-712-7509
Michigan Otolaryngology Surgery AssociatesYpsilantiMichigan48197
Paul T. Hoff, MD
[email protected]
734-712-7509

Find similar trials in Ann Arbor, MI

By research site
St. Joseph Mercy Ann Arbor· Ann Arbor, MIMichigan Otolaryngology Surgery Associates· Ypsilanti, MI

Related Studies