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临床试验/NCT04555993
NCT04555993Unknown不适用

Comparison Between Ultrasound-Guided Transversus Abdominis Plane Block and Ultrasound-Guided Erector Spinae Plane Block in Postoperative Analgesia for Lower Abdominal Cancer Surgery. Randomised Double Blinded Control Study

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
62
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.

详细描述

Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction.

The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.

Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.

Both blocks haven't been compared to each other in this type of surgery before.

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, Outcomes Assessor)

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

  • Physical status ASA II.
  • Age ≥ 18 and ≤ 65 Years.
  • Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
  • Patient is able to provide a written informed consent.
  • Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

排除标准

  • Age <18 years or >65 years.
  • BMI <20 kg/m2 and >40 kg/m
  • Known sensitivity to local anaesthetics and morphine.
  • History of psychological disorders and/or chronic pain.
  • Significant liver or renal insufficiency.
  • Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
  • Patient refusal.
  • Severe respiratory or cardiac disorders.
  • Pregnancy.
  • ASA III-IV.

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours

The total amount of morphine which was consumed post-operatively measured in milligrams

次要结局

  • Intraoperative fentanyl consumption.(intraoperative)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Shaban Mohammed

Assistant lecturer of anesthesia and critical care medicine

National Cancer Institute, Egypt

研究点 (1)

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