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Идёт набор NCT06878014

Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery

Фаза IV С лечением Analgesics, Opioid Anesthesia, Spinal Total Hip Replacement Adverse Anesthesia Outcome

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: Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen, PCA IV Oxycodone, Postoperative pain management with dexketoprofen.
Кому может быть актуально
Состояния в реестре: Analgesics, Opioid, Anesthesia, Spinal, Total Hip Replacement, Adverse Anesthesia Outcome. 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
Польша
Следующий шаг
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Официальное название

Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.

Обзор

Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression. To limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks. The aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.

Вмешательства

  • Процедура Spinal Anesthesia (bupivacaine)
    Patients were positioned in sitting position on operating table, interspinous space was identified using anatomical landmarks (intercristal line) and palpation. Entire procedure was conducted with aseptic technique, puncture site was prepared with izopropyl alcohol solution. Skin was anesthetized with subcutaneous injection of 1% lidocaine. Spinal puncture was achieved using median or paramedian technique with 27G pencil-point spinal needle. After confirmation of free flow of cerebrospinal fluid
  • Препарат Postoperative pain management with acetaminophen
    Postoperatively patients received 1,0g of paracetamol every 6 hours,
  • Устройство PCA IV Oxycodone
    All patients were equipped with PCA capable syringe pump (Perfusor Space, B. Braun) with 40 milligrams of oxycodone. Care provider explained thoroughly how to operate the device and educated about possible adverse effects.
  • Препарат Postoperative pain management with dexketoprofen
    Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
  • Препарат Postoperative pain management with metamizole
    Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
  • Препарат Preemptive Analgesics
    After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
  • Устройство Patient monitor
    Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.

Первичные конечные точки

  • Analgesic efficacy [Срок оценки: 48 hours postoperatively]
  • Safety profile [Срок оценки: 48 hours postoperatively]
Вторичные конечные точки (4)
  • Patient satisfaction [Срок оценки: 48 hours postoperatively]
  • Length of stay [Срок оценки: Up to one week.]
  • Time to rescue analgesia [Срок оценки: 48 hours postoperatively]
  • Cumulative dose of oxycodone [Срок оценки: 48 hours postoperatively]

Критерии участия

Критерии включения

  • Informed consent to participate in trial
  • Qualification for total hip replacement surgery
  • ASA physical status I-III
  • BMI 19-30
  • Lack of contraindications for drugs and interventions used in trial

Критерии исключения

  • Incapability to provide informed consent
  • Contraindications for spinal anesthesia
  • Preoperative chronic pain
  • Chronic use of analgesics
  • Obesity (BMI>30)
  • Allergies and other contraindications for drugs used in trial
  • Mental or physical incapability to operate PCA syringe pump

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

Польша · 3 центра
  • Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary — Sosnowiec
  • Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie — Szczecin
  • Zespół Opieki Zdrowotnej w Końskich — Gmina Końskie

Идентификаторы

NCT: NCT06878014 · SMD-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗