BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty

Официальное название

Infiltration of Local Anesthetics Between the Popliteal Artery and Capsule of the Knee (iPACK) With Femoral Triangle Block (TFB) Versus Surgical Local Infiltration Analgesia (LIA) in Unilateral Total Knee Arthroplasty (TKA): A Multicenter Double-blind, Prospective Randomized Controlled Study.

Обзор

The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.

Вмешательства

• Процедура Locoregional anesthesia
  The FTB + iPACK group will receive 12 ml 0,5% ropivacaine for the FTB and 20 ml of ropivacaine 0.5% for the iPACK block under US guidance after spinal anesthesia
• Процедура Local Anesthetic Ropivacaine
  The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Первичные конечные точки

• Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively [Срок оценки: 8 hours postoperatively]

Вторичные конечные точки (10)

• NRS pain at movement for the first 24 hours [Срок оценки: 24 hours postoperatively]
• NRS pain at rest for the first 24 hours [Срок оценки: 24 hours postoperatively]
• Rate of popliteal block 8 hours after surgery [Срок оценки: 8 hours postoperatively]
• Functional recovery: timed up and go test [Срок оценки: Baseline, 24 hours and 48 hours after surgery]
• Functional recovery: 30-second sit-to-stand-chair test [Срок оценки: Baseline, 24 hours and 48 hours after surgery]
• Quality of Life: Short-form 36 (SF-36) questionnaire [Срок оценки: Baseline, 3 months, 6 months]
• Quality of Life: WOMAC questionnaire [Срок оценки: Baseline, 3 months, 6 months]
• Incidence of rescue blocks [Срок оценки: 8 to 12 hours after the spinal anesthesia]
• Need for rescue analgesia [Срок оценки: during hospital stay, an average of 3 days]
• Time to be fit for discharge [Срок оценки: during hospital stay, an average of 3 days]

Критерии участия

Критерии включения

• ASA I-III
• BMI 17-35 kg/m2
• Patient is able to give informed consent
• Patient is scheduled for TKA

Критерии исключения

• Refusal of patient
• Inability to communicate due to language or neurologic barriers
• Bilateral TKA or unilateral knee arthroplasty
• Chronic opioid use (including partial opioid agonists) + chronic pain patients:
• Use of atypical analgesics (gabapentin, pregabalin, …)
• History of Sudeck atrophy
• History of >3 chronic pain consultations
• Contraindications for spinal anesthesia
• Patient refusal
• Local infection
• Aberrant coagulation (according to the latest ESRA guidelines)
• Severe spinal canal stenosis
• Intracranial hypertension
• History of neurological injury in the affected limb
• Contraindications for local anesthetics
• Allergy for local anesthetics
• Absolute contraindications for NSAIDs or paracetamol
• Proven allergy for NSAID's (including ASA syndrome) or paracetamol
• Severe renal function impairment (eGFR <30 ml/min/1.73 m2)
• Active or recent (<6 months) history of gastric ulcera/perforations/bleeding
• Crohn disease or colitis ulcerosa
• Liver function impairment or severe renal function impairment (eGFR <30 ml/min/1.73 m2)
• Pregnancy or breast-feeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Jessa Hospital — Hasselt

Идентификаторы

NCT: NCT06746168 · 2024/178

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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