Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to perform block.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Full term pregnant women
- •Older than 21 years of age
- •Had elective cesarean section with Pfannenstiel incision.
排除标准
- •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.
研究组 & 干预措施
surgical TAP block
twenty-five pregnant women will receive 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.
干预措施: surgical TAP block (Procedure)
US guided TAP block
25 pregnant women will receive US guided T.A.P 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.
干预措施: US guided TAP block (Procedure)
结局指标
主要结局
Time to perform block.
时间窗: 1 hour postoperatively
The time taken to perform the block will be recorded by an independent observer.
次要结局
- Mean arterial blood pressure(24 hours postoperatively)
- Heart rate(24 hours postoperatively)
- Amount of post operative analgesic consumption(24 hours postoperatively)
- Incidence of Adverse reactions(24 hours postoperatively)
- Pain score(24 hours postoperatively)
- Time to first analgesic request(24 hours postoperatively)
- Time spent in operating room(24 hours postoperatively)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University