Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
17. srpna 2026 aktualizováno: Washington University School of Medicine
Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia: A Randomized Clinical Trial
The purpose of this study is to find out which pain medication is more effective in reducing pain after nose surgery (rhinoplasty).
The investigators are looking to find the best treatment to reduce discomfort and improve the healing process for patients having nose surgery.
Přehled studie
Postavení
Nábor
Podmínky
Intervence / Léčba
Detailní popis
The investigators are comparing two types of pain relief medications: Liposomal Bupivacaine and Standard Bupivacaine.
Participants who are undergoing rhinoplasty will be randomly assigned to receive either Liposomal Bupivacaine or Standard Bupivacaine during their surgery.
Both medications are given as nerve blocks, which means they are injected near nerves to block pain signals. After the surgery, participants will be asked to rate their pain levels over several days.
The investigators will also monitor any side effects and how quickly participants recover from the surgery.
Typ studie
Intervenční
Zápis (Odhadovaný)
45
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Matthew Wu, MD
- Telefonní číslo: 314-362-0524
- E-mail: mjwu@wustl.edu
Studijní záloha kontaktů
- Jméno: Sara Kukuljan, BS, RN
- Telefonní číslo: 314-362-7563
- E-mail: kukuljas@wustl.edu
Studijní místa
-
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Nábor
- Washington University
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Kontakt:
- Sara Kukuljan, BS, RN
- Telefonní číslo: 314-362-7563
- E-mail: kukuljas@wustl.edu
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Adult patients (≥18 years) undergoing open rhinoplasty of any indication or complexity (e.g., primary, revision, functional, or cosmetic), including autologous grafting of any type (e.g., septal or costal cartilage) or cadaveric grafting.
Exclusion Criteria:
- Chronic pain condition requiring ongoing or scheduled analgesic therapy, or any diagnosis associated with chronic pain (e.g., fibromyalgia, chronic headache/migraine, neuropathic pain, complex regional pain syndrome), long-term opioid use (≥3 months, any agent), allergy or contraindication to local anesthetics, acetaminophen, ibuprofen / NSAIDs, tramadol, ketamine, Medrol (methylprednisolone) dose pack
- Concurrent non-nasal surgery planned
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Liposomal Bupivacaine
Participants randomized to the experimental arm will receive bilateral supraorbital and infraorbital nerve blocks using liposomal bupivacaine at the end of surgery.
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Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
Ostatní jména:
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Aktivní komparátor: Standard Bupivacaine
The control arm will receive standard bupivacaine nerve blocks using the same injection sites and volumes appropriate for safe regional anesthesia
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Volume: 4 mL of 0.75% bupivacaine hydrochloride
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cumulative opioid consumption
Časové okno: First 72 hours postoperatively
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Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME).
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First 72 hours postoperatively
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Vomiting
Časové okno: Postoperative day 0 through postoperative day 7
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Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Postoperative day 0 through postoperative day 7
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Constipation
Časové okno: Postoperative day 0 through postoperative day 7
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Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Postoperative day 0 through postoperative day 7
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Rash
Časové okno: Postoperative day 0 through postoperative day 7
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Incidence of rash, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Postoperative day 0 through postoperative day 7
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Adherence to ERAS Multimodal Analgesic Regimen
Časové okno: Postoperative day 0 through postoperative day 7
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Patient adherence to the Enhanced Recovery After Surgery (ERAS) multimodal analgesic regimen, assessed using daily postoperative surveys, calculated as total number of pills taken / total number of pills prescribed x 100, with adherence defined as ≥80%.
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Postoperative day 0 through postoperative day 7
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Block site safety
Časové okno: Preoperative baseline and one month postoperatively
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Proportion of participants with ≥1 new-onset injection-site or sensory adverse event, assessed by a 10-item binary patient-reported questionnaire at the supraorbital and infraorbital block sites.
New-onset defined as negative at baseline and positive at follow-up.
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Preoperative baseline and one month postoperatively
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Adverse Events
Časové okno: Postoperative day 0 through one month postoperatively
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Capturing any adverse events classified according to prespecified criteria described in the protocol.
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Postoperative day 0 through one month postoperatively
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Modified Brief Pain Inventory - Pain Outcomes
Časové okno: Postoperative day 0 through postoperative day 7
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Patient-reported pain intensity and pain interference measured using the Modified Brief Pain Inventory (mBPI).
Pain intensity is assessed with 3 items (average, current, and worst pain over the last 24 hours) and pain interference with 3 items (general activity, mood, and sleep).
Each item is rated on a 0 to 10 numeric rating scale (0 = no pain / does not interfere; 10 = worst pain imaginable / completely interferes).
Higher scores indicate a worse outcome.
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Postoperative day 0 through postoperative day 7
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Modified Brief Pain Inventory - Pain relief from analgesic medication
Časové okno: Postoperative day 0 through postoperative day 7
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Patient-reported relief from pain medication, measured using the corresponding item of the Modified Brief Pain Inventory (mBPI).
The item is rated on a 0 to 10 numeric rating scale (0 = no relief; 10 = complete relief).
Higher scores indicate a better outcome (greater pain relief).
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Postoperative day 0 through postoperative day 7
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Nausea
Časové okno: Postoperative day 0 through postoperative day 7
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Incidence of nausea, an opioid-related symptom, defined as the percentage of participants reporting any nausea on daily postoperative self-report surveys.
Nausea is captured on a 0 to 10 rating and dichotomized as present (score ≥ 1) or absent (score 0) for this outcome.
Reported as the percentage of participants (0% to 100%); a higher percentage indicates a worse outcome.
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Postoperative day 0 through postoperative day 7
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Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction
Časové okno: Preoperative baseline and one month postoperatively
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Patient-reported nasal obstruction measured using the obstruction domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS-O).
The obstruction domain score is normalized to a 0 to 100 scale, where higher scores indicate a worse outcome (greater nasal obstruction).
Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.
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Preoperative baseline and one month postoperatively
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Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis
Časové okno: Preoperative baseline and one month postoperatively
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Patient-reported cosmesis measured using the cosmesis domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS-C).
The cosmesis domain score is normalized to a 0 to 100 scale, where higher scores indicate a worse outcome (greater dissatisfaction with nasal appearance).
Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.
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Preoperative baseline and one month postoperatively
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Matthew Wu, MD, Washington University School of Medicine
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
- Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Anesthesiology. 2021 Feb 1;134(2):283-344. doi: 10.1097/ALN.0000000000003630.
- Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
- McAlvin JB, Padera RF, Shankarappa SA, Reznor G, Kwon AH, Chiang HH, Yang J, Kohane DS. Multivesicular liposomal bupivacaine at the sciatic nerve. Biomaterials. 2014 May;35(15):4557-64. doi: 10.1016/j.biomaterials.2014.02.015. Epub 2014 Mar 6.
- Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
- Richard BM, Rickert DE, Newton PE, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. Safety Evaluation of EXPAREL (DepoFoam Bupivacaine) Administered by Repeated Subcutaneous Injection in Rabbits and Dogs: Species Comparison. J Drug Deliv. 2011;2011:467429. doi: 10.1155/2011/467429. Epub 2011 Oct 5.
- Safa B, Flynn B, McHardy PG, Kiss A, Haslam L, Henry PD, Kaustov L, Choi S. Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine Versus 1% Ropivacaine for Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1129-1137. doi: 10.1213/ANE.0000000000005373.
- Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S. Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):576-83. doi: 10.1097/AAP.0000000000000420.
- Hah JM, Cramer E, Hilmoe H, Schmidt P, McCue R, Trafton J, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Mackey SC, Carroll I. Factors Associated With Acute Pain Estimation, Postoperative Pain Resolution, Opioid Cessation, and Recovery: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190168. doi: 10.1001/jamanetworkopen.2019.0168.
- Moubayed SP, Ioannidis JPA, Saltychev M, Most SP. The 10-Item Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) for Functional and Cosmetic Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):37-42. doi: 10.1001/jamafacial.2017.1083.
- Justicz N, Gadkaree SK, Yamasaki A, Lindsay RW. Defining Typical Acetaminophen and Narcotic Usage in the Postoperative Rhinoplasty Patient. Laryngoscope. 2021 Jan;131(1):48-53. doi: 10.1002/lary.28531. Epub 2020 Feb 7.
- Sclafani AP, Kim M, Kjaer K, Kacker A, Tabaee A. Postoperative pain and analgesic requirements after septoplasty and rhinoplasty. Laryngoscope. 2019 Sep;129(9):2020-2025. doi: 10.1002/lary.27913. Epub 2019 Mar 7.
- Alameddine KO, Richards BA, Vyas K, Chaudhry A, Millesi E, Hamilton GS, Bite U. Evaluating the Efficacy of Liposomal Bupivacaine in Postoperative Pain Management for Rhinoplasty: A Retrospective Study. Aesthetic Plast Surg. 2024 May;48(9):1722-1727. doi: 10.1007/s00266-023-03656-w. Epub 2023 Sep 29.
- Ye Q, Asherman J, Stevenson M, Brownson E, Katre NV. DepoFoam technology: a vehicle for controlled delivery of protein and peptide drugs. J Control Release. 2000 Feb 14;64(1-3):155-66. doi: 10.1016/s0168-3659(99)00146-7.
- Marchand GJ, Masoud AT, Ware K, King A, Ruther S, Brazil G, Cieminski K, Calteux N, Coriell C, Ulibarri H, Parise J, Arroyo A, Chen YC, Pierson M, Rafie R, Sainz K. A Systematic Review and Meta-Analysis of the Effect of Intraoperative Bupivacaine in Gynaecologic Surgery After 24 Hours or 9 Half-Lives. J Obstet Gynaecol Can. 2021 Nov;43(11):1279-1287. doi: 10.1016/j.jogc.2021.06.010. Epub 2021 Jul 19.
- The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: a Single-blinded, Prospective Clinical Trial. National Library of Medicine (US). https://clinicaltrials.gov/study/NCT05964868
- FDA. EXPAREL- bupivacaine injection, suspension, liposomal. FDA2024
- FDA. MARCAINE - bupivacaine hydrochloride injection, solution. 2012.
- Hu KS, Kwak J, Koh KS, Abe S, Fontaine C, Kim HJ. Topographic distribution area of the infraorbital nerve. Surg Radiol Anat. 2007 Jul;29(5):383-8. doi: 10.1007/s00276-007-0227-z. Epub 2007 Jun 22.
- Shin KJ, Shin HJ, Lee SH, Song WC, Koh KS, Gil YC. Emerging Points of the Supraorbital and Supratrochlear Nerves in the Supraorbital Margin With Reference to the Lacrimal Caruncle: Implications for Regional Nerve Block in Upper Eyelid and Dermatologic Surgery. Dermatol Surg. 2016 Aug;42(8):992-8. doi: 10.1097/DSS.0000000000000818.
- Nedeljkovic SS, Kett A, Vallejo MC, Horn JL, Carvalho B, Bao X, Cole NM, Renfro L, Gadsden JC, Song J, Yang J, Habib AS. Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial. Anesth Analg. 2020 Dec;131(6):1830-1839. doi: 10.1213/ANE.0000000000005075.
- Gadsden J, Hamilton M, Schwartz G, Gonzales J, Hutchins J, Saha P, Song J, DiGiorgi M, Winston R. A Phase 3 Active-Controlled Trial of Liposomal Bupivacaine via Adductor Canal Block for Total Knee Arthroplasty. J Arthroplasty. 2025 Oct;40(10):2605-2614.e5. doi: 10.1016/j.arth.2025.07.030. Epub 2025 Jul 22.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. června 2027
Dokončení studie (Odhadovaný)
1. července 2027
Termíny zápisu do studia
První předloženo
30. června 2026
První předloženo, které splnilo kritéria kontroly kvality
30. června 2026
První zveřejněno (Aktuální)
8. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202601024
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .