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Adjunct Exparel (bupivacaine liposome suspension 1.3%) for Tonsillectomy (EXPCT Trial)

Phase 4

Waitlist Available

Research Sponsored by Paul Hoff

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-tonsillectomy days 1, 2, 3, 5, and 10

Awards & highlights

EXPCT Trial Summary

This trial is exploring whether a long-acting local anesthetic can help manage pain experienced by adult patients after tonsillectomy.

EXPCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-tonsillectomy days 1, 2, 3, 5, and 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-tonsillectomy days 1, 2, 3, 5, and 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-tonsillectomy days 1, 2, 3, 5, and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days

Secondary outcome measures

Change in the total amount of over the counter pain medication taken between Day-1 and designated post-operative days

Change in total amount of prescribed narcotic pain medication taken between Day-1 and designated post-operative days

Other outcome measures

Adverse Event

Change in the amount of fluid intake consumed between Day-1 and designated post-operative days

Time to change in food intake

+1 more

EXPCT Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard CareExperimental Treatment1 Intervention

Group II: Adjunct ExparelExperimental Treatment2 Interventions

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.

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