Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
2026年8月17日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
45
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Matthew Wu, MD
- 电话号码：314-362-0524
- 邮箱：mjwu@wustl.edu
研究联系人备份
- 姓名：Sara Kukuljan, BS, RN
- 电话号码：314-362-7563
- 邮箱：kukuljas@wustl.edu
学习地点
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Missouri
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St Louis、Missouri、美国、63110
- 招聘中
- Washington University
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接触：
- Sara Kukuljan, BS, RN
- 电话号码：314-362-7563
- 邮箱：kukuljas@wustl.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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
其他名称：
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有源比较器：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
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cumulative opioid consumption
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Vomiting
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Matthew Wu, MD、Washington University School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636.
- Alfirevic A, Almonacid-Cardenas F, Yalcin EK, Shah K, Kelava M, Sessler DI, Turan A. Blood bupivacaine concentrations after pecto-serratus and serratus anterior plane injections of plain and liposomal bupivacaine in robotically-assisted mitral valve surgery: Sub-study of a randomized trial. J Clin Anesth. 2024 Aug;95:111470. doi: 10.1016/j.jclinane.2024.111470. Epub 2024 Apr 10.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年6月30日
首先提交符合 QC 标准的
2026年6月30日
首次发布 (实际的)
2026年7月8日
研究记录更新
最后更新发布 (实际的)
2026年8月18日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.