EXPAREL Post-tonsillectomy Clinical Trial

Phase 4

• Conditions: Tonsillectomy
• Interventions: Other: Standard Care; Drug: Adjunct Exparel (bupivacaine liposome suspension 1.3%)

• Registration Number: NCT03420638
• Lead Sponsor: Paul Hoff

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.

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Study Start: 2018-02-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	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.
Adjunct Exparel	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. 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.
Adjunct Exparel	Adjunct Exparel (bupivacaine liposome suspension 1.3%)	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.

Primary Outcome Measures

Name	Time	Method
Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days	Post-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.

Secondary Outcome Measures

Name	Time	Method
Change in total amount of prescribed narcotic pain medication taken between Day-1 and designated post-operative days	Post-tonsillectomy Days 1, 2, 3, 5, and 10	Patient reported amount of prescribed narcotic pain medication in mg. taken during a 24-hour period. Higher values represent greater amounts of narcotic pain medication consumed and a worse outcome. Day-1 begins at 12:00 AM (midnight after the day of surgery and extends through 11:59 PM. Day-2 and each following designated day will begin at 12:00 AM and will extend through 11:59 PM.
Change in the total amount of over the counter pain medication taken between Day-1 and designated post-operative days	Post-tonsillectomy Days 1, 2, 3, 5, and 10	Patient reported amount of over the counter pain medication taken in mg during a 24-hour period. Higher values represent greater amounts of over the counter pain medication consumed and a worse outcome. Day-1 begins at 12:00 AM (after midnight) day of surgery and will extend through 11:59 PM. Day-2 and each following designated day will begin at 12:00 AM and will extend through 11:59 PM.

Trial Locations

Locations (2)

St. Joseph Mercy Ann Arbor; 🇺🇸 Ann Arbor, Michigan, United States

Michigan Otolaryngology Surgery Associates; 🇺🇸 Ypsilanti, Michigan, United States