EXPAREL Post-tonsillectomy Clinical Trial

NCT03420638 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: HSR-17-1714
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Conditions

Tonsillectomy

Keywords

Adults; Pain

Outcome Measures

Primary Outcomes (1)

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

  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.

  Post-tonsillectomy Days 1, 2, 3, 5, and 10

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (4)

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

  Post-tonsillectomy Days 1, 2, 3, 5, and 10

• Time to change in food intake

  Post-tonsillectomy Days 1, 2, 3, 5, and 10

• Time to first physical activity outside of the home

  Post-tonsillectomy Days 1, 2, 3, 5, and 10

Study Arms (2)

Adjunct Exparel

EXPERIMENTAL

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.

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

Standard Care

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.

Other: Standard Care

Interventions

Adjunct Exparel (bupivacaine liposome suspension 1.3%) 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.

Also known as: Bupivacaine liposome suspension 1.3%

Adjunct Exparel

Standard Care 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.

Also known as: Bupivacaine HCl with epinephrine

Adjunct Exparel; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paul Hoff: lead
• St. Joseph Mercy Ann Arbor: collaborator

Study Sites (2)

St. Joseph Mercy Ann Arbor

Ann Arbor, Michigan, 48106, United States

RECRUITING

Michigan Otolaryngology Surgery Associates

Ypsilanti, Michigan, 48197, United States

RECRUITING

Related Publications (11)

• 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.

  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.

  PMID: 28346375 BACKGROUND

• 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.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 21812940 RESULT

• 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.

  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.

  PMID: 24815964 RESULT

MeSH Terms

Conditions

Pain

Interventions

Standard of Care; Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Paul T Hoff, MD

CONTACT

734-712-7509; Paul.Hoff@stjoeshealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using sealed envelope assignment, the participant will be placed in study Arm 1 or 2. The PI will not be masked because the PI will administer the adjunct treatment or the standard of care only. The outcome assessor will be masked to study group assignment for gathering data from trial participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: February 5, 2018
• Study Start: February 15, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)