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临床试验/NCT07479069
NCT07479069进行中(未招募)不适用

Effect of Bilateral Erector Spinae Plane Block on Postoperative Opioid Consumption in Open Abdominal Surgeries Under General Anaesthesia

Fatima Memorial Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
46
试验地点
1
主要终点
Postoperative Opioid Consumption

研究概览

简要总结

his randomized controlled trial aims to evaluate the efficacy of the bilateral erector spinae plane (ESP) block in reducing postoperative opioid consumption in patients undergoing open abdominal surgeries under general anesthesia

详细描述

Patients undergoing abdominal surgeries experience severe postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating the analgesic effects and complications associated with the bilateral ESP block. The study involves 46 patients allocated into two groups using a lottery method: a control group receiving standard pain control treatment, and an erector spinae block group receiving a bilateral ESP block in addition to standard pain control treatment. Pain intensity will be evaluated using a visual analogue scale (VAS) at 4, 8, 12, and 24 hours after the operation.

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
None

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 Anesthesiology (ASA) stage I-II.
  • Scheduled for abdominal surgery due to any indication.

排除标准

  • History of Diabetes
  • History of neuropathic diseases
  • History of gastrointestinal bleeding, peptic ulcer, or inflammatory bowel disease
  • History of long-term nonsteroidal anti-inflammatory
  • History of chronic opioid analgesic use
  • History of severe hepatic or renal failure

研究组 & 干预措施

Control Group

Active Comparator

Patients receiving standard pain control treatment. Postoperatively, patients receive 1000 mg of IV paracetamol every 6 hours. If a patient reports a Visual Analogue Score (VAS) exceeding five, they will receive rescue analgesia consisting of nalbuphine 4mg

干预措施: Standard Postoperative Analgesia (Drug)

Erector Spinae Block Group

Experimental

Patients receiving bilateral ESP block in addition to standard pain control treatment

干预措施: Bilateral Erector Spinae Plane (ESP) Block (Procedure)

Erector Spinae Block Group

Experimental

Patients receiving bilateral ESP block in addition to standard pain control treatment

干预措施: Standard Postoperative Analgesia (Drug)

结局指标

主要结局

Postoperative Opioid Consumption

时间窗: Within the first 24 hours after surgery

Assessed by the percentage of patients requiring rescue opioid analgesia. The need for rescue analgesia is determined by a Visual Analogue Score (VAS) greater than five

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

Fatima Majeed

Principal Investigator

Fatima Memorial Hospital

研究点 (1)

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