Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

Официальное название

Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial

Обзор

The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

Подробное описание

Caesarean delivery rates have been increasing worldwide nowadays. At rate of \[52%\], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries.

A much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

Вмешательства

• Процедура surgical TAP block
  performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.
• Процедура US guided TAP block
  performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.

Первичные конечные точки

• Time to perform block. [Срок оценки: 1 hour postoperatively]

Вторичные конечные точки (7)

• Heart rate [Срок оценки: 24 hours postoperatively]
• Mean arterial blood pressure [Срок оценки: 24 hours postoperatively]
• Pain score [Срок оценки: 24 hours postoperatively]
• Time to first analgesic request [Срок оценки: 24 hours postoperatively]
• Amount of post operative analgesic consumption [Срок оценки: 24 hours postoperatively]
• Time spent in operating room [Срок оценки: 24 hours postoperatively]
• Incidence of Adverse reactions [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

• Full term pregnant women
• Older than 21 years of age
• Had elective cesarean section with Pfannenstiel incision.

Критерии исключения

• Patients with cesarean section using different surgical incision
• History of addiction \[including opioids and benzodiazepines\]
• Allergy to the anesthetic analgesia
• Psychological disorders
• Coagulopathies
• Infection at the block injection site.

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

Египет · 1 центр

• Kohaf — Cairo

Идентификаторы

NCT: NCT05750992 · DFM-IRB 00012367- 23-02-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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