[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03420638":3,"trial-entities:NCT03420638":131,"trial-summary:NCT03420638":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":94,"overall_officials":96,"references":97,"see_also_links":130},"NCT03420638","HSR-17-1714","EXPAREL Post-tonsillectomy Clinical Trial","Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults","RECRUITING","2021-12-31","2021-05","2021-05-19","2018-02-15","Paul Hoff","OTHER",true,"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\u002FmL) when used as a post-excision adjunct to the standard of care bupivacaine HCl 0.25% (2.5 mg\u002FmL) with Epinephrine (5mcg\u002FmL), 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.",[19],"Tonsillectomy",[21,22],"Adults","Pain","INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},38,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"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\u002FmL) with epinephrine (5 mcg\u002FmL) 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\u002FmL\\] 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\u002FmL) on each side.",[36],"Adjunct Exparel",[38],"Bupivacaine liposome suspension 1.3%",{"type":14,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"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\u002F mL) with epinephrine (5 mcg\u002FmL) 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.",[36,40],[44],"Bupivacaine HCl with epinephrine",[46],{"measure":47,"description":48,"timeFrame":49},"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",[51,54],{"measure":52,"description":53,"timeFrame":49},"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":55,"description":56,"timeFrame":49},"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.","ALL","18 Years",null,false,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Scheduled to undergo bilateral palatine tonsillectomy as the only procedure\n2. Adults age 18 years and older.\n\nExclusion Criteria:\n\n1. Severe systemic disease that is clinically significant in the judgement of the investigator.\n2. Coagulation disorder that is clinically significant in the judgement of the investigator.\n3. Current or previous history of analgesic dependence\n4. Allergy to any of the drugs used in the study (bupivacaine)\n5. Women known to be pregnant, planning to become pregnant, or lactating\n6. Hearing impairment that is clinically significant in the judgement of the investigator.\n7. Cardiovascular disease that is clinically significant in the judgement of the investigator.\n8. Impaired liver function that is clinically significant in the judgement of the investigator.\n9. Impaired renal function that is clinically significant in the judgement of the investigator.\n10. Unable to provide consent.\n11. Additional surgical procedures planned concurrently with palatine tonsillectomy.\n12. Planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.",[66,67],"ADULT","OLDER_ADULT",[69,84],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"St. Joseph Mercy Ann Arbor","Ann Arbor","Michigan","48106","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Paul T Hoff, MD","CONTACT","734-712-7509","Paul.Hoff@stjoeshealth.org",{"lat":82,"lon":83},42.27756,-83.74088,{"facility":85,"status":8,"city":86,"state":72,"zip":87,"country":74,"contacts":88,"geoPoint":91},"Michigan Otolaryngology Surgery Associates","Ypsilanti","48197",[89],{"name":90,"role":78,"phone":79,"email":80},"Paul T. Hoff, MD",{"lat":92,"lon":93},42.24115,-83.61299,[95],{"name":77,"role":78,"phone":79,"email":80},[],[98,101,104,107,110,113,116,119,122,125,127],{"type":99,"citation":100},"BACKGROUND","2. Marcaine™ [package insert]. Hospira, Inc., Lake Forest, IL; October 2011. https:\u002F\u002Fwww.accessdata.fda.gov\u002Fdrugsatfda_docs\u002Flabel\u002F2012\u002F022046s004lbl.pdf. Accessed June 12, 2017.",{"pmid":102,"type":99,"citation":103},"28346375","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\u002Fpharmaceutics9020012.",{"type":105,"citation":106},"RESULT","1. Exparel® [package insert]. Pacira Pharmaceuticals, Inc., San Diego, CA; 2015. https:\u002F\u002Fwww.exparel.com\u002Fsites\u002Fdefault\u002Ffiles\u002FEXPAREL_Prescribing_Information.pdf. Accessed June 12, 2017.",{"pmid":108,"type":105,"citation":109},"19294964","Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25.",{"pmid":111,"type":105,"citation":112},"18983373","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\u002Fj.1749-4486.2008.01815.x.",{"pmid":114,"type":105,"citation":115},"24281921","Bhattacharyya N, Kepnes LJ. Revisits and postoperative hemorrhage after adult tonsillectomy. Laryngoscope. 2014 Jul;124(7):1554-6. doi: 10.1002\u002Flary.24541. Epub 2014 Jan 3.",{"pmid":117,"type":105,"citation":118},"20069307","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\u002Fs00405-009-1200-8. Epub 2010 Jan 13.",{"pmid":120,"type":105,"citation":121},"16929992","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":123,"type":105,"citation":124},"21812940","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\u002Fj.1749-4486.2011.02373.x.",{"type":105,"citation":126},"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:\u002F\u002Fvideos.med.wisc.edu\u002Fvideos\u002F56752. Accessed July 10, 2017.",{"pmid":128,"type":105,"citation":129},"24815964","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\u002Fj.bpa.2014.02.001. Epub 2014 Mar 15.",[],{"nct_id":4,"conditions":132,"biomarkers":133},[19],[],{"nct_id":4,"found":15,"summary":135,"prompt_version":145},{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 38 adult participants.","completed","EXPAREL for Post-Tonsillectomy Pain","This study is looking at ways to manage pain after a tonsillectomy (surgery to remove your tonsils). It compares two approaches: the standard pain medication, bupivacaine HCl 0.25% with epinephrine, and a combination of this standard medication with Exparel (bupivacaine liposome suspension 1.3%). Researchers want to see if adding Exparel helps reduce pain, especially in the first three days after surgery, and if it lowers the need for other pain medications. You may be able to join if you are an adult (18 years or older) scheduled for a tonsillectomy. The study aims to enroll 38 participants. The success of the study will be measured by changes in your pain rating from right after surgery up to 10 days later. The current status of this study is unclear.","Your pain will be monitored for 10 days after your tonsillectomy.",128,"After your tonsils are removed and before you wake up from anesthesia, the study doctor will inject medication into the surgical area. Your pain levels will be measured on days 1, 2, 3, 5, and 10 after surgery.","Not stated in the trial record.",[],"v2"]