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临床试验/NCT05136118
NCT05136118已完成不适用

Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section

Ain Shams University1 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2021年11月1日最近更新:
适应症

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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada M.Samir

Assistant Professor of Anesthesia, Intensive care and Pain Management

Ain Shams University

研究点 (1)

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