Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Time to rescue analgesia
研究概览
简要总结
Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.
Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.
详细描述
Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I and ∏
- •primigravidas
- •aged 21-40 years
- •body weight ˃ 60 kg
- •singleton pregnancy
- •gestational age of ≥37 weeks
- •undergoing elective caesarean section under spinal anesthesia.
排除标准
- •Parturient refusal
- •parturient with a BMI > 40
- •body weight < 60 kg
- •ASA physical status ≥ III
- •known local anesthetic (LA) allergy •contraindications to spinal anesthesia
- •parturients who received analgesics in the past 24 hours
- •infection at the site of the block.
研究组 & 干预措施
Group MS
The modified surgeon assisted approach for TAPB Before the closure of the peritoneum, TAPB will be performed; at the level of the umbilicus 8 to 10cms from the midline bilaterally. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin slightly directed towards the ipsilateral anterior superior iliac spine. After feeling the 2 pops of the external and the internal oblique aponeurosis by the anesthesiologist, the surgeon will confirm proper needle placement by his hand inside the abdominal cavity. The LA will be injected after negative aspiration and a bleb will be palpated by the surgeon as the injection continues. The same procedure will be repeated on the other side.
干预措施: TAPB (Procedure)
Group US
The ultra-sound guided approach for TAPB. After abdominal wall closure, the linear probe of the ultra- sound will be placed perpendicular to the skin at the mid-axillary line between the iliac crest and the costal margin; the TAP will be located between the internal oblique and the transversus abdominis muscle. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin and the 2 pops of the external and the internal oblique aponeurosis will be also felt. The LA will be injected after negative aspiration and its spread in the plane will be observed. The same procedure will be repeated on the other side.
干预措施: TAPB (Procedure)
结局指标
主要结局
Time to rescue analgesia
时间窗: 6 months
the time from the end of surgery until the first parturient's request for analgesia
次要结局
- Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia(6 months)
- Number of parturients requiring postoperative analgesia(6 months)
- Total dose of pethidine given(6 months)
- Time to the parturient's first ambulation(6 months)
- The analgesic satisfaction 24 hours after operation(6 months)
研究者
Ghada M.Samir
Assistant Professor of Anesthesia, Intensive care and Pain Management
Ain Shams University