Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty

Официальное название

Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty: a Randomized Controlled Trial

Обзор

Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Poor acute postoperative pain control impacts rehabilitation, prolongs recovery and increases opioid consumption and chronic post-surgical pain. Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals Inc, Parsippany, New Jersey, USA) is a multivesicular formulation of bupivacaine that prolongs drug release and can extend the duration of analgesia. The adductor canal block (ACB) has been shown to reduce pain intensity and opioid consumption after total knee arthroplasty. The use of liposomal bupivacaine in the adductor canal block has recently been FDA-approved. However, the results of its efficacy from existing clinical trials have been mixed. In addition, the doses in the clinical trials have been different, and the optimal dose for perineural application of liposomal bupivacaine is unclear, including for the adductor canal block. In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of different doses of liposomal bupivacaine in the adductor canal block on acute postoperative pain intensity and opioid consumption after robotic assisted total knee arthroplasty. The investigators will also assess secondary outcomes including knee functional scores, chronic pain and quality of recovery.

Вмешательства

• Препарат 0.5% standard bupivacaine only
  20ml 0.5% standard bupivacaine only
• Препарат 1.33% liposomal bupivacaine with 0.5% standard bupivacaine
  10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
• Препарат 1.33% liposomal bupivacaine only
  20ml 1.33% liposomal bupivacaine (266mg)

Первичные конечные точки

• Weighted area under curve (AUC) pain score [Срок оценки: The first 48 hours after surgery when the patient is at rest]

Вторичные конечные точки (12)

• NRS pain scores [Срок оценки: from after surgery to postoperative day 7]
• Oxynorm consumption [Срок оценки: Postoperative day 1-7]
• Overall Benefit of Analgesic Score (OBAS) [Срок оценки: Postoperative day (POD) 1-7]
• Plasma level of bupivacaine and ropivacaine [Срок оценки: Blood will be collected during induction, at 12 hours, 24 hours, 48 hours, and 72 hours after ACB.]
• Quality of Recovery Questionnaire (QoR-9) [Срок оценки: Postoperative day 1]
• Rehabilitation parameters (range of maximal active knee flexion) [Срок оценки: While the patient is in hospital from postoperative day 0, day 1, and day 2.]
• Rehabilitation parameters (quadricep power) [Срок оценки: While the patient is in hospital from postoperative day 0, day 1, and day 2.]
• Rehabilitation parameters (ability to perform straight leg raising) [Срок оценки: While the patient is in hospital from postoperative day 0, day 1, and day 2.]
• Rehabilitation parameters (walking distance) [Срок оценки: While the patient is in hospital from postoperative day 0, day 1, and day 2.]
• Rehabilitation parameters (Duration of hospital stay) [Срок оценки: estimated on average of postoperative day 7 at the date of discharge from hospital]
• Rehabilitation parameters (discharge location) [Срок оценки: estimated on average of postoperative day 7 at the date of discharge from hospital]
• Opioid-related side effects [Срок оценки: While the patient is in hospital from postoperative day 0, 1, and 2.]

Критерии участия

Критерии включения

• ASA I-III
• Age 18-80 years old
• Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery
• Able to speak and understand Cantonese or Mandarin or English
• Able to provide informed oral and written consent

Критерии исключения

• Revision TKA
• Single-stage bilateral TKA
• Complex primary TKA requiring use of stem/augment/constrained liner
• Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring fixation
• Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
• History of chronic pain other than chronic knee pain
• History of immunosuppression
• Chronic use of glucocorticoids
• Chronic opioid use (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
• History of congestive heart failure (NYHA 2)
• Alcohol or drug abuse
• Impaired renal function (defined as effective glomerular filtration rate < 30ml/min/1.73m2
• Impaired liver function (defined as plasma bilirubin over 34mol/L; international normalized ratio \[INR\] >= 1.7, alanine aminotransferase \[ALT\] over 100U/L, aspartate aminotransferase \[AST\] over 100U/L)
• Coagulopathy (platelet count <100,000/ml and/or INR >= 1.5) or the use of anticoagulants (not including aspirin) that precludes the use of adductor canal blocks
• Pre-existing neurological or muscular disorders
• Psychiatric illness
• Impaired mental state
• Pregnancy
• Local infection
• On immunosuppressants
• High body mass index (BMI) (>=40)
• Patient refusal for regional nerve blocks or to conduct clinical trial

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The University of Hong Kong — Гонконг

Публикации

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• Portenoy R. Development and testing of a neuropathic pain screening questionnaire: ID Pain. Curr Med Res Opin. 2006 Aug;22(8):1555-65. doi: 10.1185/030079906X115702. PMID 16870080
• Chan MT, Lo CC, Lok CK, Chan TW, Choi KC, Gin T. Psychometric testing of the Chinese quality of recovery score. Anesth Analg. 2008 Oct;107(4):1189-95. doi: 10.1213/ane.0b013e318184b94e. PMID 18806027
• Lam ET, Lam CL, Fong DY, Huang WW. Is the SF-12 version 2 Health Survey a valid and equivalent substitute for the SF-36 version 2 Health Survey for the Chinese? J Eval Clin Pract. 2013 Feb;19(1):200-8. doi: 10.1111/j.1365-2753.2011.01800.x. Epub 2011 Nov 29. PMID 22128754
• Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, Eikermann M. Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J Anaesth. 2010 Oct;105(4):511-8. doi: 10.1093/bja/aeq186. Epub 2010 Aug 6. PMID 20693179
• Cohen, J., Statistical power analysis for the behavioral sciences. 2013: routledge.
• Quaye A, McAllister B, Garcia JR, Nohr O, Laduzenski SJ, Mack L, Kerr CR, Kerr DA, Razafindralay CN, Richard JM, Craig WY, Rodrigue S. A prospective, randomized trial of liposomal bupivacaine compared to conventional bupivacaine on pain control and postoperative opioid use in adults receiving adductor canal blocks for total knee arthroplasty. Arthroplasty. 2024 Feb 1;6(1):6. doi: 10.1186/s42836-02 PMID 38297390
• Malige A, Pellegrino AN, Kunkle K, Konopitski AK, Brogle PJ, Nwachuku CO. Liposomal Bupivacaine in Adductor Canal Blocks Before Total Knee Arthroplasty Leads to Improved Postoperative Outcomes: A Randomized Controlled Trial. J Arthroplasty. 2022 Aug;37(8):1549-1556. doi: 10.1016/j.arth.2022.03.073. Epub 2022 Mar 26. PMID 35351553

Идентификаторы

NCT: NCT06740214 · UW24-691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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