EXPAREL Post-tonsillectomy Clinical Trial

NCT ID: NCT03420638

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2021-12-31

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.

Conditions

Tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Adjunct Exparel

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.

Group Type: EXPERIMENTAL

Adjunct Exparel (bupivacaine liposome suspension 1.3%)

Intervention Type: DRUG

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 1.3% (13.3 mg/mL) on each side.

Standard Care

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Standard Care

Intervention Type: OTHER

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.

Interventions

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 1.3% (13.3 mg/mL) on each side.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Bupivacaine liposome suspension 1.3%; Bupivacaine HCl with epinephrine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph Mercy Ann Arbor

UNKNOWN

Sponsor Role: collaborator

Paul Hoff

OTHER

Sponsor Role: lead

Responsible Party

Paul Hoff

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

St. Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Michigan Otolaryngology Surgery Associates

Ypsilanti, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul T Hoff, MD

Role: CONTACT

Paul.Hoff@stjoeshealth.org

734-712-7509

Facility Contacts

Paul T Hoff, MD

Role: primary

Paul.Hoff@stjoeshealth.org

734-712-7509

Paul T. Hoff, MD

Role: primary

Paul.Hoff@stjoeshealth.org

734-712-7509

References

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Reference Type: BACKGROUND

Bulbake U, Doppalapudi S, Kommineni N, Khan W. Liposomal Formulations in Clinical Use: An Updated Review. Pharmaceutics. 2017 Mar 27;9(2):12. doi: 10.3390/pharmaceutics9020012.

Reference Type: BACKGROUND

PMID: 28346375 (View on PubMed)

1. Exparel® [package insert]. Pacira Pharmaceuticals, Inc., San Diego, CA; 2015. https://www.exparel.com/sites/default/files/EXPAREL_Prescribing_Information.pdf. Accessed June 12, 2017.

Reference Type: RESULT

Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25.

Reference Type: RESULT

PMID: 19294964 (View on PubMed)

Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-9. doi: 10.1111/j.1749-4486.2008.01815.x.

Reference Type: RESULT

PMID: 18983373 (View on PubMed)

Bhattacharyya N, Kepnes LJ. Revisits and postoperative hemorrhage after adult tonsillectomy. Laryngoscope. 2014 Jul;124(7):1554-6. doi: 10.1002/lary.24541. Epub 2014 Jan 3.

Reference Type: RESULT

PMID: 24281921 (View on PubMed)

Stelter K, Hiller J, Hempel JM, Berghaus A, Hagedorn H, Andratschke M, Canis M. Comparison of two different local anaesthetic infiltrations for postoperative pain relief in tonsillectomy: a prospective, randomised, double blind, clinical trial. Eur Arch Otorhinolaryngol. 2010 Jul;267(7):1129-34. doi: 10.1007/s00405-009-1200-8. Epub 2010 Jan 13.

Reference Type: RESULT

PMID: 20069307 (View on PubMed)

Arikan OK, Ozcan S, Kazkayasi M, Akpinar S, Koc C. Preincisional infiltration of tonsils with ropivacaine in post-tonsillectomy pain relief: double-blind, randomized, placebo-controlled intraindividual study. J Otolaryngol. 2006 Jun;35(3):167-72.

Reference Type: RESULT

PMID: 16929992 (View on PubMed)

Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.

Reference Type: RESULT

PMID: 21812940 (View on PubMed)

10. Tamm-Daniels, Inge. Liposomal Bupivacaine: What Is All The Fuss? University of Wisconsin School of Medicine and Public Health Madison, 5 Nov 2014-video Department of Anesthesiology grand Rounds https://videos.med.wisc.edu/videos/56752. Accessed July 10, 2017.

Reference Type: RESULT

Tong YC, Kaye AD, Urman RD. Liposomal bupivacaine and clinical outcomes. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):15-27. doi: 10.1016/j.bpa.2014.02.001. Epub 2014 Mar 15.

Reference Type: RESULT

PMID: 24815964 (View on PubMed)

Other Identifiers

HSR-17-1714

Identifier Type: -

Identifier Source: org_study_id