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临床试验/NCT04016688
NCT04016688已完成不适用

Comparative Study Between the Analgesic Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section

Fayoum University3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
3
主要终点
duration of analgesia of the two blocks

研究概览

简要总结

The aim of work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section.

详细描述

Inclusion criteria:

  • Parturients aged 18 - 40 years with American Society of Anesthesiologists physical status І or ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Exclusion criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.

Participants will be randomly divided into two groups:

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
Single (Outcomes Assessor)

盲法说明

Single-blind

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •aged 18 - 40 years
  • •American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

排除标准

  • •Patient refusal.
  • •Contraindications to regional anesthesia.
  • •Known allergy to the study drugs.
  • •Severe cardiovascular, renal or hepatic diseases.
  • •Bleeding disorders.
  • •Local infection.

研究组 & 干预措施

ES Erector Spinae Plane Block

Active Comparator

bilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process.

A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.

干预措施: ESPB and TAP block (Procedure)

TAP Transversus Abdominis Plane Block

Active Comparator

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

干预措施: ESPB and TAP block (Procedure)

结局指标

主要结局

duration of analgesia of the two blocks

时间窗: 24 hours

time

次要结局

  • Visual analogue scale(24 hours)
  • the first request to analgesia(24 hours)
  • total analgesic consumption(24 hours)
  • Visual analogue scale(immediatiy in pacu)
  • Visual analogue scale(4 hours)
  • Visual analogue scale(8 hours)
  • Visual analogue scale(12 hours)

研究者

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

Mohamed Ahmed Hamed

Anesthesia lecturer

Fayoum University

研究点 (3)

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