EXPAREL Post-tonsillectomy Clinical Trial (EXPCT)

Paul Hoff

Status and phase: Unknown; Phase 4

Conditions: Tonsillectomy

Treatments: Other: Standard Care; Drug: Adjunct Exparel (bupivacaine liposome suspension 1.3%)

Study type: Interventional

Funder types: Other

Identifiers

NCT03420638

HSR-17-1714

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Adjunct Exparel

Experimental group

Description:

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.

Treatment:

Other: Standard Care

Drug: Adjunct Exparel (bupivacaine liposome suspension 1.3%)

Standard Care

Other group

Description:

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.

Treatment:

Other: Standard Care