Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery
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: Fentanyl 1, Fentanyl2, Fentanyl 3.
- Кому может быть актуально
- Состояния в реестре: Obstetric Pain. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial
Обзор
Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery
Подробное описание
In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 %, morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl. The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patient's treatment. For 24 hours following surgery, each patient would receive intravenous patient-controlled morphine analgesia. In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 % and morphine sulfate 100 mcg. The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. For 24 hours following surgery, each patient would receive intravenous patient- controlled morphine analgesia.
Вмешательства
- Процедура Fentanyl 1
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and no fentanyl - Процедура Fentanyl2
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 10 mcg of of fentanyl - Процедура Fentanyl 3
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 20 mcg of fentanyl
Первичные конечные точки
- Patient Controlled Analgesia morphine consumption [Срок оценки: Day 1 after cesarean section]
- obstetric quality of recovery score [Срок оценки: Day 1 after cesarean section]
Вторичные конечные точки (7)
- Visual Analogue Scale [Срок оценки: Day 1 after cesarean section]
- pruritus [Срок оценки: Day 1 after cesarean section (and day 0 for intraoperative pruritus)]
- nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity [Срок оценки: Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)]
- intraoperative hypotension [Срок оценки: during the cesarean section]
- intraoperative opioids [Срок оценки: during the cesarean section]
- satisfaction rate [Срок оценки: Day 1 after cesarean section]
- intraoperative pain [Срок оценки: during the surgery]
Критерии участия
Критерии включения
- patients over 18 year of age
- height over 160 cm
- American Society Anesthesiologists physical status I and II
- term singleton parturients
- scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli
Критерии исключения
- patients with inability to consent
- patient refusal
- contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)
- emergency cesarean delivery
- preeclampsia/eclampsia
- allergy to drugs used in the protocol
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- Ospedale Regionale di Bellinzona, San Giovanni — Bellinzona
Идентификаторы
NCT: NCT06355271 · 2024-00019