Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement

Официальное название

Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement: a Prospective, Single-center, Simple Randomized, Active-controlled, Single-blind, 2x2 Factorial Design Clinical Study

Обзор

The purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in TKA ( total knee replacement ) patients.The main questions answered are: 1. Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement 2. Which block method(Femoral triangle block or adductor block) combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery. investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block. Participants will: 1. Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. 2. Undergo total knee replacement surgery under spinal anesthesia. 3. Follow-up within 72 hours after surgery , opioid consumption, NRS score, PCA（Patient controlled analgesia，PCA） data, first postoperative remedial analgesia time, quadriceps muscle strength and complications were recorded

Подробное описание

The patients received femoral triangle block plus iPACK(infiltration between popliteal artery and capsule of knee) block or adductor canal block plus iPACK block during induction .

The local anesthetic formulation was bupivacaine (0.75% bupivacaine hydrochloride 10ml+ normal saline 20ml) or bupivacaine liposome (0.75% bupivacaine hydrochloride 10ml+ bupivacaine liposome 20ml(266mg)).

Вмешательства

• Препарат Bupivacaine liposome
  Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
• Процедура Nerve block mode : adductor block
  Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.
• Препарат Bupivacaine
  Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
• Процедура Nerve block mode: femoral triangle block
  Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.

Первичные конечные точки

• Opioid consumption 72 hours after surgery [Срок оценки: this outcome will be monitored and recorded within 72 hours postoperatively]

Вторичные конечные точки (4)

• Pain intensity [Срок оценки: Pain intensity will be measured at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery]
• Time to First Rescue Analgesic [Срок оценки: 72 hours after surgery]
• Total opioid dosage and PCA times [Срок оценки: Total opioid dosage and PCA times were recorded at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery]
• Quadriceps muscle strength [Срок оценки: 24.48,72 hours after surgery]

Критерии участия

Критерии включения

• Patients with ASAI-ⅲ
• Receive a unilateral initial TKA
• Age 18-80 years old -

Критерии исключения

• Bilateral TKA surgery
• TKA revision surgery
• Contraindications for nerve block and intraspinal anesthesia
• Allergies to local anesthetics
• Diabetic neuropathy
• Patients who are unable to cooperate with the evaluation
• Chronic use of opioid analgesics
• BMI≥35kg/cm2
• Cases of lumbar anesthesia failure requiring general anesthesia surgery
• Cases of nerve block failure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Lingli DENG — Ухань

Публикации

• Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3 PMID 31056239
• Song L, Li Y, Xu Z, Geng ZY, Wang DX. Comparison of the ultrasound-guided single-injection femoral triangle block versus adductor canal block for analgesia following total knee arthroplasty: a randomized, double-blind trial. J Anesth. 2020 Oct;34(5):702-711. doi: 10.1007/s00540-020-02813-8. Epub 2020 Jun 12. PMID 32533332

Идентификаторы

NCT: NCT06653621 · TJ-IRB202409095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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