Effect of Adding Two Different Doses of Hyaluronidase to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Post-cesarean Section Analgesia; A Randomized Controlled Double Blinded Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- the duration of analgesia
研究概览
简要总结
Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Hence, the present study was carried out to evaluate the efficacy of hyaluronidase in different concentrations added to bupivacaine in US-guided bilateral lateral TAP block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •parturients who aged between 18-40 years old
- •with ASA physical status grade II and
- •scheduled for elective CS under spinal anesthesia
排除标准
- •patients with ASA grade III or IV,
- •refusal to participate,
- •emergency CS or complicated pregnancy,
- •those with bleeding disorders or on anticoagulants,
- •those with severe respiratory and cardiovascular diseases,
- •having any local infection at the injection site,
- •history of allergy to one of the used drugs,
- •obese patients (body mass index ≥ 30 kg/m2).
研究组 & 干预措施
Group H1
patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 750 IU hyaluronidase as an adjuvant in each side after closing skin.
干预措施: Hyaluronidase (Drug)
Group H2
patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 1500 IU hyaluronidase as an adjuvant in each side after closing skin.
干预措施: Hyaluronidase (Drug)
Group C
patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline without any adjuvant in each side after closing skin.
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
the duration of analgesia
时间窗: 24 hours postoperative
the interval between performing the block and the time of the first request for analgesia.
次要结局
- the postoperative pain severity(every 0,2,4,8,12, up to 24 hours postoperative)
- patient satisfaction(at 24 hours postoperatively)
- total morphine consumption(at 24 hours postoperatively)
研究者
Samar Rafik Mohamed Amin
Doctor
Benha University