Clinical trial NCT03420638: EXPAREL Post-tonsillectomy Clinical Trial
Official title: Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tonsillectomy
Keywords: Adults
Pain
Lead sponsor: Saint Joseph Mercy Health System
Sponsor class: OTHER
Collaborators: name: St. Joseph Mercy Ann Arbor
First posted: 2018-02-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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 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

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% (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.

Eligibility 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.

Primary outcomes:
measure: Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
Secondary outcomes:
measure: Change in total amount of prescribed narcotic pain medication taken between Day-1 and designated post-operative days
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
measure: Change in the total amount of over the counter pain medication taken between Day-1 and designated post-operative days
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
Other outcomes:
measure: Change in the amount of fluid intake consumed between Day-1 and designated post-operative days
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
measure: Time to change in food intake
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
measure: Time to first physical activity outside of the home
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
measure: Adverse Event
timeFrame: Post-tonsillectomy Days 1, 2, 3, 5, and 10
Locations:
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Ann Arbor
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Otolaryngology Surgery Associates
state: Michigan
Study officials:
References:
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