The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks

Официальное название

The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ultrasound-guided Ankle Blocks in Patients Undergoing Hallux Valgus Repair Surgery - a Randomized, Double-blinded, Parallel-group Interventional Study

Обзор

Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair, with or without minor concomitant toe procedures. Many factors influence the onset and duration of peripheral nerve blocks. In the advent of ultrasound-guided nerve blocks, the accuracy in administering LA has significantly improved, potentially reducing the required dosage, which is also associated with less risk for toxicity. However, the effect of the concentration of LA on the onset time and duration of ultrasound-guided ankle blocks for forefoot surgery has not yet been studied. This poses a clinically relevant dilemma regarding the necessity of administering lower or higher concentrations of ropivacaine to achieve a clinically relevant faster onset time and longer duration of an ankle block.

Подробное описание

This study aims to evaluate the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the onset time and duration of ultrasound-guided ankle blocks in patients having forefoot surgery for anesthesia and postoperative analgesia. We hypothesize that the use of 1% ropivacaine for ultrasound guided ankle blocks will result in a significantly faster onset time and a longer sensory block duration, and thus analgesia, compared to the use of 0.25% and 0.5% ropivacaine in patients having forefoot surgery. The primary outcome is the difference in the duration of the sensory blocks. The secondary outcomes are the difference in onset time of the sensory block, motor function, the postoperative pain scores, opioid consumption, and proportion of failed blocks.

Вмешательства

• Препарат 0.25% ropivacaine
  A total of 15 ml of 0.25% ropivacaine will be administered and distributed strategically among the specific nerves: 6 ml for the tibial nerve, 3 ml for the deep peroneal nerve, and 2 ml each for the superficial peroneal nerve, saphenous nerve, and sural nerve.
• Препарат 0.5% ropivacaine
  A total of 15 ml of 0.5% ropivacaine will be administered and distributed strategically among the specific nerves: 6 ml for the tibial nerve, 3 ml for the deep peroneal nerve, and 2 ml each for the superficial peroneal nerve, saphenous nerve, and sural nerve.
• Препарат 1% ropivacaine
  A total of 15 ml of 1% ropivacaine will be administered and distributed strategically among the specific nerves: 6 ml for the tibial nerve, 3 ml for the deep peroneal nerve, and 2 ml each for the superficial peroneal nerve, saphenous nerve, and sural nerve.

Первичные конечные точки

• Duration [Срок оценки: 48 hours]

Вторичные конечные точки (5)

• Onset [Срок оценки: 30 minutes]
• Motor function [Срок оценки: 48 hours]
• Pain scores [Срок оценки: 48 hours]
• Opioid consumption [Срок оценки: 48 hours]
• Proportion failed blocks [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• Provide signed and dated informed consent
• Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair, with or without one or more of the following: minor toe procedures, osteotomies, arthrodesis or toe extensor/flexor procedures, under unilateral ankle block at ZOL Genk
• ASA physical I-II-III
• Able to ambulate (ability to walk independently, with or without assistive devices)
• Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick/cold/ light touch sensation test) as the patient will have to perform these sensory and motor assessments by him/herself at home at postoperative day 0 to 2

Критерии исключения

• Language barrier
• Preexisting lower extremity neuropathy
• Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)
• Contraindications for use of NSAIDs
• Allergy to local anesthetics
• Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
• Weight below 50 kg based on a maximum dose of 3 mg/kg ropivacaine and a maximum dose of 150 mg ropivacaine.
• Preoperative use of opioids or gabapentin less than 3 days before surgery
• Contraindications for use of paracetamol
• Contraindications for use of tramadol

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

Лечение

Центры проведения

Бельгия · 1 центр

• Ziekenhuis Oost-Limburg — Genk

Идентификаторы

NCT: NCT06185608 · ROADS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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