Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
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: Dexmedetomidine, fentanyl, Saline 0.9%.
- Кому может быть актуально
- Состояния в реестре: Vaginal Delivery, Normal Labor. Базовые параметры: Без ограничений · 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: Single Shot Intrathecal Bupivacaine With Fentanyl Versus Bupivacaine With Dexmedetomidine in Normal Labor, Randomized Control Clinical Trial
Обзор
the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor.
Подробное описание
on arrival to the operating room, the demographic and baseline data will be collected, which include sections about age, height, weight, primigravida or multigravida, cervical dilation at the time of performing labor analgesia, fetus presentation, presence of rupture of membrane, baseline pain scores will be assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) before SSSA. Intravenous access will be achieved in all patients loading will be undertaken using 500 ml Ringer's solution, baseline values of pulse rate (PR), respiratory rate (RR), hemoglobin oxygen saturation (SpO2), and arterial blood pressure (ABP) will be recorded. SSSA will be performed with the parturient in the sitting position under complete aseptic precautions at the L3-L4 level using a 25-gauge spinal needles. The correct positioning of the needle tip in the intrathecal space will be confirmed by the observation of a free flow of cerebrospinal fluid, and then the prefilled study drug will be injected intrathecally which is 2.5 mg bupivacaine plus 25 mic fentanyl or 5 mic dexmedetomidine or 0.5 ml saline according to different groups.
parturient will then turn to the supine position, and a wedge will be placed under the right buttocks to prevent aortocaval compression. VAS will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours. If VAS 8 or more the instigators will give the patient 50 mg intramuscular pethidine.
Maternal blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded noninvasively every 5 min for the first half hour, followed by every 20 min for 3 hours, then every 1 h for next 3 hours. the investigators will give 5 mg ephedrine if there is hypotension ( decrease in ABP more than 25% of the baseline ABP) and .5 mg atropine if there is bradycardia (HR less than 50 beats per minute). Side effects such as hypotension, nausea, vomiting, bradycardia, shivering, pruritus, and tachycardia will be recorded. The first- and fifth-minute Apgar scores will also be recorded. The onset, duration of analgesia, and obstetric and neonatal outcomes will be compared.
Вмешательства
- Препарат Dexmedetomidine
5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine - Препарат fentanyl
25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine - Препарат Saline 0.9%
0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine
Первичные конечные точки
- the duration and onset of analgesia. [Срок оценки: baseline, pre intervention and after intervention for an average 6 hours]
- the change in visual analogue scale (VAS) of the labor pain. [Срок оценки: baseline, pre intervention and after intervention an average 6 hours]
Вторичные конечные точки (5)
- maternal satisfaction assessed using a satisfaction questionnaire. [Срок оценки: At delivery/birth]
- change in maternal hemodynamics as blood pressure. [Срок оценки: baseline, pre intervention and after intervention for an average 6 hours]
- change in maternal hemodynamics as heart rate [Срок оценки: baseline, pre intervention and after intervention for an average 6 hours]
- change in maternal hemodynamics as respiratory rate. [Срок оценки: baseline, pre intervention and after intervention for an average 6 hours.]
- Apgar score at 1 and 5 minutes. [Срок оценки: will be recorded 1 minute after delivery and 5 minutes after delivery.]
Критерии участия
Критерии включения
- ASA I-II.
- Uncomplicated pregnancy.
- At term \& singleton fetus.
- Cervical dilatation > 5cm
- Cephalic presentations
Критерии исключения
- Patient refusal.
- Bleeding disorders and patients on anticoagulant drugs.
- Infection at site of injection.
- Spine deformity.
- Allergy to any of study medications.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Aswan University Hospital — Aswān
Публикации
- Eldemrdash AM, Elsawy TTD, Zaher ZZ, Younan JS, Ragheb AMR. Single-Shot Intrathecal Bupivacaine With Fentanyl vs. Dexmedetomidine for Labor Analgesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Apr 29;2026:6685169. doi: 10.1155/anrp/6685169. eCollection 2026. PMID 42063584
Идентификаторы
NCT: NCT06823349 · Asw.Uni. / 926 / 5 / 24