Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
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: Acetaminophen, NSAID (Ketorolac/Ibuprofen).
- Кому может быть актуально
- Состояния в реестре: Cesarean Delivery, Postpartum Comfort, Postpartum Pain, Post-operative Pain. Базовые параметры: от 16 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
- США
- 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
PACESS: Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
Обзор
Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.
Подробное описание
Cesarean delivery is a commonly performed surgical procedure. The rate of cesarean delivery (CD) is increasing in the US; cesarean accounted for 32% of all births in 2022. Parents who deliver via CD experience more pain than those who have a vaginal birth. Uncontrolled postpartum pain can be associated with an increased risk of physical complications including venous thrombosis, atelectasis, pneumonia as well as increased psychological distress. Poor postpartum pain control can also hinder infant-parental bonding and impact breastfeeding initiation or continuation.
Multiple strategies for post-operative pain management exist including opioid and non-opioid medications. Multimodal non-opioid medications are preferred as first-line therapies due to the short- and long-term risks associated with opioid pain medication. Acetaminophen and ibuprofen are most commonly utilized in the US. A meta-analysis of 21 studies enrolling 1909 post-operative patients examined the efficacy of NSAIDs and parecetamol in combination compared to each drug alone and found a significant reduction in pain intensity for combination therapy compared to each drug alone.
Both acetaminophen and ibuprofen can be given every 6 hours. Practices differ, however, on administering these medications at the same time or in a staggered fashion. To date, there are no trials comparing these different dosing schedules for post-cesarean delivery pain control.
Вмешательства
- Препарат Acetaminophen
Acetaminophen 1000 mg q6H - Препарат NSAID (Ketorolac/Ibuprofen)
NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)
Первичные конечные точки
- Postpartum pain control [Срок оценки: 48 (+/- 2) hours postpartum]
- Opioid consumption [Срок оценки: Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)]
Вторичные конечные точки (10)
- Postpartum pain at 6 hours [Срок оценки: 6 hours (+/- 1 hour) post-op]
- Postpartum pain at 12 hours [Срок оценки: 12 hours (+/-2 hours) post-op]
- Postpartum pain at 24 hours [Срок оценки: 24 hours (+/-2 hours) post-op]
- Postpartum pain at 48 hours [Срок оценки: 48 hours (+/- 2 hours) post-op.]
- Adequate pain control [Срок оценки: by 48 hours (+/-2 hours) post-op]
- Length of stay [Срок оценки: Admission to discharge (Typically 2-7 days)]
- Infant feeding [Срок оценки: At time of hospital discharge (Typically 1- 5 days post-op)]
- Patient satisfaction [Срок оценки: Post-operative day #2-5.]
- Opioid Prescription [Срок оценки: At hospital discharge (Post-operative day #2-5)]
- Home opioid [Срок оценки: Post-operative day #10-14]
Критерии участия
Критерии включения
- >/= 34 weeks gestation
- Singleton pregnancy
- Delivery via cesarean section under regional anesthesia
Критерии исключения
- Contraindication to acetaminophen or NSAIDs
- Current or history of opioid use or misuse
- Intrauterine fetal demise
- Major congenital anomaly
- Conversion to general anesthesia intra-op or planned general anesthesia
- Mid-line vertical skin incision
- Receipt of intraoperative local analgesia such as Transversus Abdominis Plan (TAP) block or wound infiltration
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Thomas Jefferson University Hospital — Philadelphia
Идентификаторы
NCT: NCT07102641 · iRISID-2024-1669