Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia

Официальное название

Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia: A Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Standard Bupivacaine
  Volume: 4 mL of 0.75% bupivacaine hydrochloride
• Препарат Liposomal Bupivacaine
  Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine

Первичные конечные точки

• Cumulative opioid consumption [Срок оценки: First 72 hours postoperatively]

Вторичные конечные точки (11)

• Modified Brief Pain Inventory - Pain Outcomes [Срок оценки: Postoperative day 0 through postoperative day 7]
• Modified Brief Pain Inventory - Pain relief from analgesic medication [Срок оценки: Postoperative day 0 through postoperative day 7]
• Nausea [Срок оценки: Postoperative day 0 through postoperative day 7]
• Vomiting [Срок оценки: Postoperative day 0 through postoperative day 7]
• Constipation [Срок оценки: Postoperative day 0 through postoperative day 7]
• Rash [Срок оценки: Postoperative day 0 through postoperative day 7]
• Adherence to ERAS Multimodal Analgesic Regimen [Срок оценки: Postoperative day 0 through postoperative day 7]
• Block site safety [Срок оценки: Preoperative baseline and one month postoperatively]
• Adverse Events [Срок оценки: Postoperative day 0 through one month postoperatively]
• Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction [Срок оценки: Preoperative baseline and one month postoperatively]
• Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis [Срок оценки: Preoperative baseline and one month postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University — St Louis

Публикации

• 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. PMID 32031696
• 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. PMID 30843623
• 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. PMID 26204387
• 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. PMID 37775576
• 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. PMID 10640654
• 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. PMID 22013534
• 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. PMID 24612918
• 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. PMID 27281722

Идентификаторы

NCT: NCT07689162 · 202601024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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