Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty.

Официальное название

Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty: a Randomized Controlled Trial.

Обзор

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedures and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. Optimal postoperative pain management after TKA is not fully defined. While multimodal analgesia is standard, the choice of associated regional anesthesia techniques is debated. Local infiltration analgesia (LIA) is widely used and provides effective pain relief without impairing early mobilization. Peripheral nerve blocks have been discussed due to the risk of motor blockade, but low-concentration local anesthetics, such as 0.1% ropivacaine, allow sensory blockade while preserving motor function. Preliminary studies suggest that this concentration is effective and safe. The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to compare the analgesic efficacy of a quadruple nerve blocks (femoral, sciatic, obturator, and lateral femoral cutaneous nerves) using 0.1% ropivacaine versus standard LIA in patients undergoing TKA.

Подробное описание

In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to the recommendations of the SFAR (French Society of Anesthesia \& Intensive Care Medecine) and an injection of 10 mg of IV dexamethasone.

The surgical procedure is a total knee arthroplasty (TKA) performed under general anesthesia (GA) with a laryngeal mask. The only difference between the two groups will be the site and technique of local anesthetic (LA) injection.

The patients will be randomized into two groups:

* LIA group (usual technique): surgical local infiltration * Quadruple nerve blocks group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks

In the operating room, general anesthesia will be induced with intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.

Other medications administered intraoperatively:

* Tranexamic acid (1 g) * Uradipil (5 mg every 3 minutes) if systolic blood pressure (SBP) \> 160 mmHg * Norepinephrine (10 µg every 3 minutes) or Ephedrine (6 mg every 3 minutes) if SBP \< 90 mmHg * Sufentanil (initial dose of 5 µg, then 5 µg every 5 minutes as needed at the anesthesiologist's discretion)

Postoperative analgesia protocol:

* Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg). * In post-anesthesia care unit (PACU): oxycodone titration if VRS (pain score) \>3 according to the centre's usual care. * In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day), oxycodone (10 mg, lockout interval: 4 h) if VRS (pain score) \>3 and cryotherapy.

Вмешательства

• Процедура Surgical local infiltration
  Injection of 150 mL of ropivacaine 0.2% into periarticular tissues according to a standardized sequence, including the posterior capsule, collateral ligaments, quadriceps, patellar tendon, capsule and subcutaneous tissue before wound closure
• Процедура Obturator nerve block
  Injection of 20 mL of 0.1% ropivacaine between the adductor magnus and adductor brevis muscles and between the adductor brevis and pectineus muscles
• Процедура Femoral nerve block
  Injection of 15 mL of 0.1% ropivacaine under the fascia iliaca, with the patient in supine position
• Процедура Sciatic nerve block
  Injection of 20 mL of 0.1% ropivacaine in the subgluteal space via a lateral approach, with the patient in prone position
• Процедура Lateral femoral cutaneous nerve block
  Injection of 5 mL of 0.1% ropivacaine lateral to the sartorius muscle

Первичные конечные точки

• Total opioid consumption within 24 hours [Срок оценки: From start of surgery (t0) to 24 hours postoperatively]

Вторичные конечные точки (12)

• Intraoperative anesthetic consumption [Срок оценки: During surgery]
• Intraoperative opioid consumption [Срок оценки: During surgery]
• Intraoperative hypertension events [Срок оценки: During surgery]
• Intraoperative hypotension events [Срок оценки: During surgery]
• Postoperative pain intensity [Срок оценки: Up to 48 hours postoperatively]
• Total opioid consumption within 48 hours [Срок оценки: From start of surgery (t0) to 48 hours postoperatively]
• Opioid-related adverse effects [Срок оценки: Up to 48 hours postoperatively]
• Quadricep motor function [Срок оценки: Postoperative days 0, 1, and 2]
• Foot elevator muscle motor function [Срок оценки: Postoperative days 0, 1, and 2]
• Ability to stand and walk [Срок оценки: Postoperative days 0, 1, and 2]
• Mobility and balance [Срок оценки: Postoperative days 0, 1, and 2]
• Functional Independence [Срок оценки: Postoperative days 0, 1, and 2]

Критерии участия

Критерии включения

• Patients undergoing primary total knee arthroplasty under general anesthesia (laryngeal mask airway)
• Fully autonomous at home
• Planned discharge to home
• Consent for participation
• Affiliation to a social security system

Критерии исключения

• Preoperative opioid use
• Chronic pain syndrome
• Valgus contraindicating sciatic nerve block
• Contraindication to any drugs used in the protocol
• Contraindication to laryngeal mask airway
• Pregnant or breastfeeding women
• Patients under protection of the adults (guardianship, curators or safeguard of justice)

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

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Clinique Médipôle Garonne — Toulouse

Идентификаторы

NCT: NCT07477730 · 2025/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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