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EXPAREL Post-tonsillectomy Clinical Trial (EXPCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03420638
Recruitment Status : Active, not recruiting
First Posted : February 2, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
St. Joseph Mercy Ann Arbor
Information provided by (Responsible Party):
Paul Hoff, Saint Joseph Mercy Health System

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

Condition or disease Intervention/treatment Phase
Tonsillectomy Drug: Adjunct Exparel (bupivacaine liposome suspension 1.3%) Other: Standard Care Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: 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.
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 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.
Other Name: Bupivacaine liposome suspension 1.3%

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.
Other Name: Bupivacaine HCl with epinephrine

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.
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.
Other Name: Bupivacaine HCl with epinephrine




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 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 ]
    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.


Other Outcome Measures:
  1. Change in the amount of fluid intake consumed between Day-1 and designated post-operative days [ Time Frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10 ]
    Patient reported amount of fluid intake in ounces during a 24-hour period. Lower values represent less fluid intake and a worse outcome.

  2. Time to change in food intake [ Time Frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10 ]
    Patient reported time in days to change in food intake from liquids to other thicker foods such as smoothies, cream soups, puddings, etc., and to solid food such as eggs, mashed vegetables, soft pasta, etc. A longer duration until a change in food intake represents a worse outcome.

  3. Time to first physical activity outside of the home [ Time Frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10 ]
    Patient reported day of first physical activity outside of the home, such as running an errand. A longer duration until physical activity outside of the home represents a worse outcome.

  4. Adverse Event [ Time Frame: Post-tonsillectomy Days 1, 2, 3, 5, and 10 ]
    Patient reported adverse event such as bleeding, Emergency Department visit, return to surgery, allergic reaction, side effects of medication, etc.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420638


Locations
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United States, Michigan
St. Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States, 48106
Michigan Otolaryngology Surgery Associates
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
Paul Hoff
St. Joseph Mercy Ann Arbor

Publications of Results:
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.
3. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009;(11):1-25. Available at: http://www.ncbi.nlm.nih.gov/pubmed/19294964. Accessed December 5, 2014.
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.

Other 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.

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Responsible Party: Paul Hoff, Principal Investigator, Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT03420638     History of Changes
Other Study ID Numbers: HSR-17-1714
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paul Hoff, Saint Joseph Mercy Health System:
Adults
Pain
Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents