Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty

Официальное название

A Randomized Trial of Liposomal Bupivacaine, Ropivacaine With Perineural Dexamethasone, and Ropivacaine With Perineural Dexmedetomidine for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty

Обзор

Effective postoperative pain management remains a cornerstone of enhanced recovery protocols following total knee arthroplasty (TKA). Inadequate analgesia not only compromises patient satisfaction but also impedes early mobilization and rehabilitation, thereby increasing the risk of perioperative complications. Current multimodal analgesic strategies frequently incorporate regional techniques, with the adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block emerging as established modalities that provide motor-sparing analgesia. Despite their widespread adoption, the optimal local anesthetic regimen for these blocks remains undefined. While liposomal bupivacaine has garnered interest for its extended duration of action, its clinical efficacy relative to conventional local anesthetics combined with perineural adjuncts remains a subject of ongoing debate. Specifically, perineural dexamethasone and dexmedetomidine have each demonstrated the capacity to prolong the analgesic duration of ropivacaine; however, direct comparative data among these three distinct strategies-liposomal bupivacaine alone versus ropivacaine supplemented with either adjunct-are notably limited. Given the absence of head-to-head randomized trials evaluating these three clinically viable techniques, the optimal approach to maximize analgesic duration while minimizing opioid-related adverse effects remains unclear. This study therefore aims to compare the analgesic efficacy and safety profiles of liposomal bupivacaine, ropivacaine with perineural dexamethasone, and ropivacaine with perineural dexmedetomidine when administered via ACB and IPACK blocks in patients undergoing TKA.

Вмешательства

• Препарат Liposomal bupivacaine (LB)
  Liposomal bupivacaine 6.65% injection. A total volume of 40 mL will be administered as ultrasound-guided adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block, divided as 20 mL for each block, prior to surgical incision.
• Препарат Ropivacaine with Perineural Dexamethasone
  Ropivacaine 0.375% combined with dexamethasone 4 mg per block (total 8 mg) as a perineural adjunct. A total volume of 40 mL will be administered as ultrasound-guided adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block, divided as 20 mL for each block
• Препарат Ropivacaine with Perineural Dexmedetomidine
  Ropivacaine 0.375% with dexmedetomidine 1 μg/kg (actual body weight). Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK

Первичные конечные точки

• Total opioid consumption [Срок оценки: 72 hours]

Вторичные конечные точки (5)

• Pain scores at rest and during movement [Срок оценки: 72 hours]
• Time to First Ambulation [Срок оценки: Postoperative day 0-2]
• Duration of Hospital Stay [Срок оценки: 0-30 days]
• Patient Satisfaction with Pain Management [Срок оценки: 24 hours, 48 hours and 27 hours postoperatively]
• Quality of Recovery [Срок оценки: Postoperative day 1-3]

Критерии участия

Критерии включения

• Patients scheduled for elective primary unilateral total knee arthroplasty
• Age ≥ 18 years and ≤ 80 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Body mass index (BMI) ≥ 18 kg/m² and ≤ 35 kg/m²
• Ability to understand and provide written informed consent

Критерии исключения

• Known allergy or contraindication to local anesthetics (bupivacaine, ropivacaine), dexamethasone, dexmedetomidine, or opioids
• Infection at the injection site
• Coagulopathy or current use of anticoagulants
• Severe cardiovascular disease (New York Heart Association \[NYHA\] functional class III or IV, or recent myocardial infarction within 6 months)
• Severe hepatic impairment (Child-Pugh class C) or renal impairment (estimated glomerular filtration rate \[eGFR\] < 30 mL/min/1.73 m²)
• Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg despite medical therapy)
• Uncontrolled diabetes mellitus (HbA1c > 8.5%)
• Bilateral TKA or revision TKA
• Chronic opioid use (daily opioid consumption for > 3 months prior to surgery)
• Participation in another interventional clinical trial within 30 days prior to enrollment
• Inability to communicate with study personnel or complete pain assessments (e.g., language barrier, cognitive impairment)

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Публикации

• Yuan Q, Shen W, He W, Wang X, Liu F, Zhang Y, Lu X, Guan Z, Zhang J, Yang L. Liposomal Bupivacaine for Adductor Canal Block Combined with IPACK Block in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. Drug Des Devel Ther. 2026 Jan 14;20:566411. doi: 10.2147/DDDT.S566411. eCollection 2026. PMID 41858908
• Yang Z, Li S, Shen M, Lei W, Huang Y, Sun J, Cheng Y, Lu X. Efficacy and safety of liposomal bupivacaine versus ropivacaine with two adjuncts in serratus anterior plane block for video-assisted thoracoscopic surgery: a protocol for a single-centre, randomised, double-blinded trial. BMJ Open. 2025 Sep 17;15(9):e102326. doi: 10.1136/bmjopen-2025-102326. PMID 40967653
• Hussain N, Brummett CM, Brull R, Alghothani Y, Moran K, Sawyer T, Abdallah FW. Efficacy of perineural versus intravenous dexmedetomidine as a peripheral nerve block adjunct: a systematic review. Reg Anesth Pain Med. 2021 Aug;46(8):704-712. doi: 10.1136/rapm-2020-102353. Epub 2021 May 11. PMID 33975918
• Liao C, Li J, Hu X, Sun Y, Zheng K, Pan X, Wang L. Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone in Adductor Canal Block for Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2026 Aug;41(8):2364-2371.e2. doi: 10.1016/j.arth.2025.11.015. Epub 2025 Nov 13. PMID 41240971
• Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111. PMID 35041742
• Desai N, Kirkham KR, Albrecht E. Local anaesthetic adjuncts for peripheral regional anaesthesia: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1:100-109. doi: 10.1111/anae.15245. PMID 33426668

Идентификаторы

NCT: NCT07509866 · WHUH20260327

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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