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临床试验/CTRI/2021/01/030754
CTRI/2021/01/030754已完成不适用

Comparison of bilateral ultrasound guided low thoracic erector spinae block and intravenous patient controlled fentanyl infusion for post-operative analgesia in lumbar surgeries – a randomised control trial.

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月31日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
1.Difference of total dose of fentanyl used in first 24 hours of post-operative period in the 2 groups.

研究概览

简要总结

Majority of the patients undergoing lumbar fusion spine surgery is associated with severe postoperative painespecially in the first post-operative period.1The pain is proportional to the number of operated vertebrae and the invasiveness of the procedure.2 Pain management following spine surgery   largely relies on opioid based protocols, which are associated with adverse effects like nausea, vomiting, pruritis, sedation and risk of long-term habituation and dependence.3 Epidural analgesia is considered gold standard for management of pain, but is associated with its own complication like interference with surgery and intrathecal migration of local anaesthetic drug.4Multimodal approaches to pain management has been demonstrated to allow for improved pain control with less reliance on opioids.5 One of the modes of multimodal analgesia is peripheral nerve blocks and interfascial plane blocks. Erector spinae plane (ESP) block is an interfascial plane blockshown to be effective in most of the thoracic surgeries.Only a few case report and case series are available regarding use of erector spinae block in lumbar surgeries.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing Lumbar spine surgeries.

排除标准

  • 1.No consent from the patient’s care-giver/ patients or attendant refusal.
  • 2.Patients having history coronary artery disease, documented clinical or echo cardiac evidence of left ventricular dysfunction.
  • 3.History of cognitive dysfunction / delirium.
  • 4.History of Opioid use.
  • 5.History of anticoagulation or any bleeding disorder.

结局指标

主要结局

1.Difference of total dose of fentanyl used in first 24 hours of post-operative period in the 2 groups.

时间窗: 1, 2, 4, 8, 12, 18 & 24 hours

次要结局

  • Difference in pain score(VAS)(1, 2, 4, 8, 12, 18 & 24 hours)
  • Time for ambulation(1, 2, 4, 8, 12, 18 & 24 hours)
  • Length of hospital stay(1, 2, 4, 8, 12, 18 & 24 hours)
  • Adverse effects of opioids:(a.Nausea vomiting)
  • Block related complications(a.Hypotension)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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