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Набор скоро начнётся NCT06935669

Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block

Фаза I С лечением Analgesia

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: Ketamine, Bupivacaine, Bupivacain.
Кому может быть актуально
Состояния в реестре: Analgesia. Базовые параметры: 21 лет — 45 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
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Официальное название

Randomised Controlled Clinical Trial Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block After Cesarean Section Under Spinal Anaesthesia

Обзор

The objective of this study is to compare the efficacy of transversalis fascia plane block using bupivacaine and ketamine versus bupivacaine alone for pain management after cesarean section under spinal anaesthesia.

Подробное описание

Cesarean section (CS) is one of the most common surgeries and usually causes moderate to severe pain for up to 48 h. The rate of CS, which is a life-saving surgical procedure in cases of certain complications that occur during pregnancy and birth, has exceeded 20% worldwide Pain control after CS has crucial importance, especially in the first 24 h, to facilitate early ambulation and the establishment of breastfeeding. Insufficient analgesia in the postoperative period may cause a number of undesirable effects, such as patient discomfort, thromboembolism due to extended immobilization, and increased pulmonary secretions resulting in complications The well-known side effects of analgesic morphine as nausea, vomiting, itching and sedation, may interfere with the interaction between mother and child, breastfeeding and post-partum experience in a dose-dependent manner. However, a number of alternative strategies have been described in order to reduce morphine consumption post-operatively .

The mode and type of analgesia should be safe and effective. A stimulus caused by a lesion in tissue or organs during surgery is the cause of postoperative pain .

The primary source of pain after abdominal surgeries, including CS, are the anterior abdominal wall and abdominal viscera, and blocking these areas could provide proper postoperative analgesia .

Recently, the application of fascial plane blocks has increased due to the widespread use of ultrasound among anesthesiologists and the avoidance of opioids in a multimodal analgesic strategy. Different regional anesthetic techniques have been introduced, including ilioinguinal nerve blocks, abdominal field blocks, Transversalis Fascia Plane (TFP) blocks, and Transversus Abdominis Plane (TAP) blocks to alleviate pain from the abdominal wall incision .

Transversalis Fascia Plane, performed in the posterior axillary line, blocks branches of L1 nerve roots, including ilioinguinal and iliohypogastric nerves. This method has been used to control postoperative pain in patients undergoing different lower abdominal surgeries A variety of anesthetic agents such as bupivacaine, levobupivacaine, and ropivacaine are commonly used in TAP blocks. These drugs provide short-term analgesia and primarily alleviate somatic pain. To extend the duration of analgesic efficacy, various adjuvants such as opioids, ketamine, clonidine, and alpha-2 agonists like dexmedetomidine have been added .

Bupivacaine is one of the widely used local analgesics. ketamine affects pain modulation through multiple mechanisms of action. It is a non-competitive N-methyl-d-aspartate (NMDA) receptor antagonist, which exerts an anti-hyperalgesic effect by decreasing central sensitization and reducing the wind-up phenomenon in the postoperative period .

The aim of this study is to investigate the effect of transversalis fascia plane block using bupivacaine plus ketamine on postoperative pain compared to bupivacaine alone in patients undergoing cesarean section under spinal anaesthesia.

Вмешательства

  • Препарат Ketamine
    Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.
  • Препарат Bupivacaine
    Control group to evaluate the additional effect of ketamine in the experimental arm.
  • Препарат Bupivacain
    Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.

Первичные конечные точки

  • The mean VAS pain on movement will be recorded as the primary outcome of the study [Срок оценки: day 1]
Вторичные конечные точки (2)
  • Time to first rescue analgesia will be recorded [Срок оценки: Day 1]
  • total requirements of rescue analgesia Nalbuphine over the first 24 hours postoperative will be recorded [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Patients aging ≥ 21 years to ≤ 45.
  • Patients undergoing cesarean section under spinal anesthesia.
  • American Society of Anesthesiologists (ASA) physical statusphysical status classes II.

Критерии исключения

  • Patient's refusal of procedure or participation in the study.
  • Coagulopathy and bleeding disorders.
  • Use of chronic pain medications.
  • Pregnancy-induced hypertension or diabetes.
  • Evidence of Local skin infections at site of injection.
  • Body mass index >40kg/m2
  • A history of relevant local anesthetic allergy.

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Египет · 1 центр
  • Ain Shams University faculty of medicine — Cairo

Публикации

  • Hassan, Shamsul Kamaruljan, et al. "Comparison of analgesic efficacy and safety of bupivacaine plus ketamine versus bupivacaine alone in rectus sheath block for midline laparotomy." Anaesthesia, Pain & Intensive Care 27.2 (2023): 154-160.

Идентификаторы

NCT: NCT06935669 · FMASU MD36/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗