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临床试验/NCT05218733
NCT05218733已完成4 期

Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine

Ain Shams University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年2月15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
120
试验地点
1
主要终点
The time for requirement of first rescue analgesic (min)

研究概览

简要总结

Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.

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
Double (Participant, Care Provider)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Body mass index (BMI) 25 to 35kg/m².
  • American Society of Anesthesiologist (ASA) physical status I or II.

排除标准

  • patient's refusal
  • Altered mental status
  • Known allergy to study drugs (bupivacaine or morphine)
  • Local infection at site of puncture.
  • Known case with any pulmonary disease
  • Known case with Obstructive sleep apnea (OSA)
  • Coagulopathy and /or thrombocytopenia
  • Chronic pain
  • Severe hepatic or kidney impairment

研究组 & 干预措施

G1 Group: (Erector Spinae Plane Block (ESPB) Group)

Active Comparator

干预措施: Ultrasound Guided Erector Spinae Plane Block (Procedure)

G2 Group: (Intra thecal morphine (ITM) Group)

Active Comparator

干预措施: Intra thecal morphine. (Drug)

G3 Group: (Control Group)

Other

干预措施: General anesthesia using intravenous fentanyl (1µgm/kg) (Drug)

结局指标

主要结局

The time for requirement of first rescue analgesic (min)

时间窗: 24 hours postoperatively

The time for requirement of first rescue analgesic (min)

次要结局

未报告次要终点

研究者

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

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain-shams University, Cairo, Egypt.

Ain Shams University

研究点 (1)

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