EXPAREL for Post-Tonsillectomy Pain

This study is looking at ways to manage pain after a tonsillectomy (surgery to remove your tonsils). It compares two approaches: the standard pain medication, bupivacaine HCl 0.25% with epinephrine, and a combination of this standard medication with Exparel (bupivacaine liposome suspension 1.3%). Researchers want to see if adding Exparel helps reduce pain, especially in the first three days after surgery, and if it lowers the need for other pain medications. You may be able to join if you are an adult (18 years or older) scheduled for a tonsillectomy. The study aims to enroll 38 participants. The success of the study will be measured by changes in your pain rating from right after surgery up to 10 days later. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 38 adult participants.
What's involved
After your tonsils are removed and before you wake up from anesthesia, the study doctor will inject medication into the surgical area. Your pain levels will be measured on days 1, 2, 3, 5, and 10 after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be monitored for 10 days after your tonsillectomy.

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NCT03420638

EXPAREL Post-tonsillectomy Clinical Trial

Recruiting
PHASE4Ages 18+InterventionalTreatment
Paul Hoff
~38 participants
Updated 2021-05-19 on ClinicalTrials.gov
What's tested:Adjunct Exparel (bupivacaine liposome suspension 1.3%)Standard Care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days
Measured over Post-tonsillectomy Days 1, 2, 3, 5, and 10
Tonsillectomy
2 sites across 1 states
Michigan2

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  • Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative daysPost-tonsillectomy Days 1, 2, 3, 5, and 10

    Patient reported average and maximum pain rating over a 24-hour period using the St. Joseph Mercy Ann Arbor (SJMAA) standard visual analog 11 point pain rating scale. The minimum value of 0 indicates no pain and the maximum value of 10 indicates the worst possible pain. A higher value represent greater pain and a worse outcome. The baseline pain rating is the maximum rating from PACU on the day of surgery. Day-1 begins at 12:00 AM (after midnight) day of surgery and extends through 11:59 PM. Each following designated day will begin at 12:00 AM and extend through 11:59 PM.