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Идёт набор NCT07092982

Comparison of Two Different Regional Anesthetic Methods in Total Knee Arthroplasty Patients

Без фазы С лечением Total Knee Arthroplasty Ultrasound Guided Supra-inguinal Fascia Iliaca Block Adductor Canal Block

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block, Ultrasound Guided iPACK Block.
Кому может быть актуально
Состояния в реестре: Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Comparison of the Effects of Ultrasound-Guided Adductor Canal Block With iPACK (Space Between the Popliteal Artery and the Posterior Knee Capsule) Block Combination and Suprainguinal Fascia Iliaca Block on Postoperative Pain and Stress Response in Patients Undergoing Total Knee Arthroplasty

Обзор

Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.

Вмешательства

  • Процедура Ultrasound Guided Suprainguinal Fascia Iliaca Block
    Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25
  • Процедура Ultrasound Guided Adductor Canal Block
    Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25
  • Процедура Ultrasound Guided iPACK Block
    Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25

Первичные конечные точки

  • Cumulative opioid consumption [Срок оценки: 24 hours]
Вторичные конечные точки (6)
  • Numeric rating scale for pain [Срок оценки: Up to 24 hours]
  • Time to first postoperative analgesic requirement [Срок оценки: Up to 24 hours]
  • Postoperative quadriceps muscle strength [Срок оценки: Up to 24 hours]
  • Incidence of postoperative nausea and vomiting [Срок оценки: Up to 24 hours]
  • Quality of Recovery 15 (QoR-15) [Срок оценки: 24 hours]
  • Inflammatory marker levels [Срок оценки: Up to 24 hours]

Критерии участия

Критерии включения

  • Patients undergoing total knee arthroplasty
  • Patients aged 18-75
  • Patients with ASA I-II-III

Критерии исключения

  • Coagulation disorders
  • Allergy to local anesthetics
  • Liver and renal failure
  • Alcohol and drug addiction
  • Cognitive dysfunction that may prevent pain assessment
  • Systemic or needle insertion site infection
  • Analgesic use for more than 3 months
  • Patient refusal to participate in the study/refusal to consent
  • Presence of a hematoma, hernia, neoplasm, etc. in the area where the block will be performed
  • Pre-existing neurological deficit
  • Patients with contraindications to nerve block

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

Turkey (Türkiye) · 1 центр
  • SB Istanbul Education and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07092982 · 56

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗