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| Name | Class |
|---|---|
| St. Joseph Mercy Ann Arbor | UNKNOWN |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total amount of prescribed narcotic pain medication taken between Day-1 and designated post-operative days | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the amount of fluid intake consumed between Day-1 and designated post-operative days | Patient reported amount of fluid intake in ounces during a 24-hour period. Lower values represent less fluid intake and a worse outcome. | Post-tonsillectomy Days 1, 2, 3, 5, and 10 |
| Time to change in food intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul T Hoff, MD | Contact | 734-712-7509 | Paul.Hoff@stjoeshealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Mercy Ann Arbor | Recruiting | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 2. Marcaineâ„¢ [package insert]. Hospira, Inc., Lake Forest, IL; October 2011. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022046s004lbl.pdf. Accessed June 12, 2017. | ||
| 28346375 | 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. | |
| Result | 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. | ||
| 19294964 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomized clinical trial
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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.
|
|
| 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. |
|
|
| 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 | 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. | 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. |
| Post-tonsillectomy Days 1, 2, 3, 5, and 10 |
| Time to first physical activity outside of the home | 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. | Post-tonsillectomy Days 1, 2, 3, 5, and 10 |
| Adverse Event | Patient reported adverse event such as bleeding, Emergency Department visit, return to surgery, allergic reaction, side effects of medication, etc. | Post-tonsillectomy Days 1, 2, 3, 5, and 10 |
| Michigan Otolaryngology Surgery Associates | Recruiting | Ypsilanti | Michigan | 48197 | United States |
|
| Result |
| Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25. |
| 18983373 | 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. |
| 24281921 | 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. |
| 20069307 | 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. |
| 16929992 | 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. |
| 21812940 | 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. |
| 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. |
| 24815964 | 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. |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
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| D010636 | Phenols |
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |