EXPAREL Post-tonsillectomy Clinical Trial

Official title

Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults

Overview

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.

Interventions

• Drug 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 l
• Other 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.

Primary outcome measures

• Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days [Time frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10]

Secondary outcome measures (2)

• Change in total amount of prescribed narcotic pain medication taken between Day-1 and designated post-operative days [Time frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10]
• Change in the total amount of over the counter pain medication taken between Day-1 and designated post-operative days [Time frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10]

Eligibility criteria

Inclusion criteria

• Scheduled to undergo bilateral palatine tonsillectomy as the only procedure
• Adults age 18 years and older.

Exclusion criteria

• Severe systemic disease that is clinically significant in the judgement of the investigator.
• Coagulation disorder that is clinically significant in the judgement of the investigator.
• Current or previous history of analgesic dependence
• Allergy to any of the drugs used in the study (bupivacaine)
• Women known to be pregnant, planning to become pregnant, or lactating
• Hearing impairment that is clinically significant in the judgement of the investigator.
• Cardiovascular disease that is clinically significant in the judgement of the investigator.
• Impaired liver function that is clinically significant in the judgement of the investigator.
• Impaired renal function that is clinically significant in the judgement of the investigator.
• Unable to provide consent.
• Additional surgical procedures planned concurrently with palatine tonsillectomy.
• Planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• St. Joseph Mercy Ann Arbor — Ann Arbor
• Michigan Otolaryngology Surgery Associates — Ypsilanti

Publications

• 2. Marcaine™ [package insert]. Hospira, Inc., Lake Forest, IL; October 2011. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022046s004lbl.pdf. Accessed June 12, 2017.
• 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. PMID 28346375
• 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.
• Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25. PMID 19294964
• 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. PMID 18983373
• 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. PMID 24281921
• 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. PMID 20069307
• 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. PMID 16929992

Identifiers

NCT: NCT03420638 · HSR-17-1714

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗