Меню
Набор скоро начнётся NCT07457814

Postoperative Pain and Analgesic Use After Total Knee Arthroplasty

— Наблюдательное Postoperative Pain After Total Knee Arthroplasty Postoperative Pain Analgesic Consumption

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Postoperative Pain After Total Knee Arthroplasty, Postoperative Pain, Analgesic Consumption. Базовые параметры: 18 лет — 100 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Postoperative Pain and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty Under General Anesthesia With Peripheral Nerve Block Versus Spinal Anesthesia With Peripheral Nerve Block

Обзор

This prospective observational study evaluates postoperative pain intensity and analgesic consumption in patients undergoing total knee arthroplasty (TKA) under different anesthesia techniques. Patients receive either general anesthesia with peripheral nerve block, spinal anesthesia with peripheral nerve block, spinal anesthesia alone, or general anesthesia with an epidural catheter. Pain scores (NRS), analgesic use, adverse effects, patient satisfaction, and the need for therapeutic interventions are assessed during the first 48 hours after surgery. The study aims to identify differences in postoperative pain control and factors associated with hypotension and other complications.

Подробное описание

This prospective, monocentric observational study evaluates postoperative pain intensity and analgesic consumption in adult patients undergoing primary total knee arthroplasty (TKA). The study focuses on anesthesia techniques routinely used in clinical practice, including general anesthesia with peripheral nerve block, general anesthesia with an epidural catheter, spinal anesthesia with peripheral nerve block, and spinal anesthesia alone.

The primary methodological aim is to compare postoperative pain trajectories (NRS) and total analgesic use during the first 48 hours after surgery across anesthesia strategies. Secondary observations include adverse effects related to analgesia, patient satisfaction, and the need for therapeutic interventions such as fluid administration, vasopressors, antiemetics, or adjustments in analgesic regimen.

Independent variables include type of anesthesia, ASA physical status, age, sex, BMI, type of peripheral nerve block, and duration of surgery. Dependent variables include postoperative pain scores, analgesic consumption, adverse events, and patient-reported satisfaction.

The study is designed to identify clinically relevant differences in postoperative pain control and to explore factors associated with hypotension and other perioperative complications. Findings may support optimization of perioperative analgesia and guide clinical decision-making in anesthesia management for TKA.

Первичные конечные точки

  • Postoperative pain intensity [Срок оценки: 6 hours, 24 hours, and 48 hours after surgery]
Вторичные конечные точки (5)
  • Analgesic consumption [Срок оценки: First 48 hours after surgery]
  • Adverse effects [Срок оценки: First 48 hours after surgery]
  • Patient satisfaction [Срок оценки: 48 hours after surgery]
  • Length of hospital stay [Срок оценки: From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).]
  • Number of participants requiring therapeutic interventions [Срок оценки: Up to 48 hours after surgery.]

Критерии участия

Критерии включения

  • Age 18-100 years
  • Primary total knee arthroplasty (TKA)
  • ASA physical status I-III
  • Glasgow Coma Scale (GCS) score of 15
  • Ability to understand study procedures and provide informed consent
  • Ability to cooperate during pre-anesthetic evaluation
  • No severe sensory impairment (e.g., blindness, deafness)

Критерии исключения

  • Revision or reoperation of TKA
  • ASA score IV or higher
  • Refusal to participate or inability to provide informed consent
  • GCS ≤ 14
  • Limited legal capacity
  • Active psychiatric disorder
  • Chronic use of strong opioid analgesics
  • Neurological disease affecting pain perception or cooperation
  • Cognitive impairment or language barrier preventing questionnaire completion
  • Use of anesthesia techniques other than GA + PNB or SA + PNB (e.g., epidural anesthesia, local infiltration without PNB)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Чехия · 1 центр
  • Tomas Bata regional hospital — Zlín

Идентификаторы

NCT: NCT07457814 · 2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗