Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section
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: Lidocaine IV, Saline 0.9%.
- Кому может быть актуально
- Состояния в реестре: Intravenous Lidocaine, Fundal Pressure, Headache. 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
- Египет
- 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
Pre-emptive Single Intravenous Lidocaine Dose to Prevent Post-Fundal Pressure Headache During Cesarean Section: The LID-HEAD Multi-center Randomized Controlled Trial
Обзор
This prospective randomized controlled multicenter study will be conducted to evaluate the effects of pre-emptive IV lidocaine dose on the incidence and severity of intraoperative headache that may occur after the extra-abdominal manual uterine fundal pressure in patients undergoing cesarean section under spinal anesthesia.
Подробное описание
This fundal pressure was previously evaluated for its effect on maternal hemodynamics during cesarean section. The investigators observed in their practice that a complaint of headache is reported by a percentage of patients immediately after fundal pressure and fetal delivery. Despite its small percentage, it had a negative impact on the maternal experience.
The proposed mechanism of this headache may be attributed to the fundal pressure-induced cushing reflex, vasopressin response, or cerebral venous engorgement all resulted from the increase in intra-abdominal pressure which can be reflected on the intra-thoracic pressure and the intracranial pressure (ICP).
Lidocaine is a local anesthetic that, when given via intravenous (IV) route could attenuate the rise in ICP during tracheal suctioning, and decrease the optic nerve sheath diameter distension during endotracheal intubation and during laparoscopy. These effects could be established by reducing cerebral blood volume through its vasoconstrictive effects on the cerebral vasculature and by decreasing electrical activity and metabolic demands through its inhibitory effects on sodium channels.
The fundal pressure maneuver is supposed to produce pathophysiological changes that resemble the previously reported factors that led to ICP elevation (intubation and pneumo-peritoneum). So, this study will be conducted as the investigators hypothesize that the administration of single IV lidocaine dose shortly before uterine fundal pressure may attenuate the temporary rise in ICP which may decrease the incidence of headache.
Вмешательства
- Препарат Lidocaine IV
IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision after ensuring negative baseline headache. - Другое Saline 0.9%
IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.
Первичные конечные точки
- Incidence of intraoperative headache [Срок оценки: Up to the end of surgery.]
Вторичные конечные точки (6)
- Severity of intraoperative headache [Срок оценки: Up to the end of surgery.]
- The changes in optic nerve sheath diameter [Срок оценки: Up to the end of surgery.]
- Incidence of shoulder pain [Срок оценки: Up to 24 hours after surgery.]
- Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores [Срок оценки: Up to 5 minutes after delivery.]
- side effects [Срок оценки: Intraoperative up to 1 hour after surgery.]
- Incidence of postoperative headache [Срок оценки: Up to 24 hours after surgery.]
Критерии участия
Критерии включения
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) Physical Status II
- Scheduled for elective cesarean section under spinal anesthesia
Критерии исключения
- Patients declined to participate in the trial,
- Patients with history of any type of headache, mental illness, or cerebrovascular diseases
- Previous epidural insertion for painless labor or any other indications;
- Patients on opioid or analgesic medications;
- Those with pregnancy-induced hypertension or diabetic patients,
- Allergy to lidocaine;
- Contraindication or failure of spinal anesthesia.
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
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Египет · 1 центр
- Tanta University Hospitals — Tanta
Идентификаторы
NCT: NCT07661758 · 36265PR75/5/26