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临床试验/NCT04941170
NCT04941170已完成4 期

U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Pre-emptive Analgesia for Open Umbilical Hernia Repair; Randomized, Double-blinded Controlled Trial

Benha University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年6月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
total morphine consumption.

研究概览

简要总结

Administration of opioids for the treatment of acute pain after open umbilical hernia repair is associated with many side effects. Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region.TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen.

详细描述

TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique and decreases postoperative pain and opioid consumption.

Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region. However, its first use was for the treatment of chronic pain, but recently it has been used as a postoperative regional analgesia technique in different surgeries from the shoulder to hip regions (3-4) The present study will be carried out to compare the preemptive analgesic efficacy between the ultrasound-guided bilateral ESP block versus bilateral oblique subcostal TAP block on patients undergoing open umbilical hernia repair.

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
Double (Participant, Investigator)

盲法说明

Double-blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of anesthesiologists I-II, scheduled for open umbilical hernia repair.
  • Age range of 18-65 years.

排除标准

  • patient refusal.
  • Patients belonging to ASA grade III and grade IV.
  • Extreme obesity (BMI >35).
  • hepatic or renal insufficiency.
  • preoperative cognitive dysfunction or communication disorder.
  • allergy to amide-type local anaesthetics.
  • back puncture site infection.
  • Coagulation disorders, pregnancy, drug abusers.

研究组 & 干预措施

Group (T)

Active Comparator

receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.

干预措施: Bupivacain (Drug)

Group (T)

Active Comparator

receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.

干预措施: Bupivacaine (Drug)

Group (E)

Active Comparator

receive preoperative bilateral ultrasound-guided erector spinae plane block.

干预措施: Bupivacain (Drug)

Group (E)

Active Comparator

receive preoperative bilateral ultrasound-guided erector spinae plane block.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

total morphine consumption.

时间窗: in first 24 hours

Amount of morphine used as rescue analgesia post-operatively.

次要结局

  • time of first analgesic request(in 24 hours)
  • pain severity evaluation.(at PACU admission , 30 minutes , 2 hours , 4 hours , 8 hours ,12 hours ,18 hours and 24 hours post operative)
  • Intraoperative fentanyl consumption(From the start of operation till its end up to 3 hours.)

研究者

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

Fatma Ahmed Abdel Fatah

Lecturer

Benha University

研究点 (1)

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