跳至主要内容
临床试验/NCT06270654
NCT06270654招募中不适用

Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery

University of Malaya2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery

研究概览

简要总结

The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery.

详细描述

Most open spine surgery exacts a high degree of postsurgical pain due to the incision and muscle dissection of the vertebra. The postoperative pain control and early mobilization improve the quality of the surgical care. Inadequate pain relief might result in perioperative morbidity, resulting in prolonged hospital stays.

Erector spinae plane block (ESPB) is an interfascial plane block where local anaesthetic is injected in a plane preferably below the erector spinae muscle. It can provide thoracic, abdominal, and even some lower extremity analgesia. It was also theorised that erector spinae plane block can reduce opioid use and provide analgesia for lumbar surgery. The financial cost that is saved by reducing the length of hospital stay, perioperative morbidity will warrant the use of erector spinae plane block in patients undergoing lumbar spine surgery.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75
  • Patients with Glasgow Coma Scale of
  • American Society of Anaesthesiologists (ASA) Physical Status Classification I - II patients
  • Scheduled for elective, open microscopic lumbar surgery (less than 3 levels) under general anesthesia.

排除标准

  • Cognitive impairment
  • Patient refusal
  • Weight<50kg, >120kg
  • Allergy to local anesthesia
  • Alcohol/ drug abuse
  • Renal failure or liver failure
  • Coagulopathy/thrombocytopenia
  • Chronic pain with chronic opioid usage
  • Ischemic heart disease

研究组 & 干预措施

Control group

Active Comparator

Pre incision of 0.375% ropivacaine 10ml local infiltration will be given.

干预措施: Skin infiltration LA (Procedure)

Ropivacaine group

Experimental

Bilateral erector spinae plane block (0.375% 20ml ropivacaine on each side + adrenaline 1:200,000) pre incision.

干预措施: Erector spinae plane block (Procedure)

结局指标

主要结局

Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery

时间窗: 24 hours

Measure by numerical rating scale (minimum 1-least pain, maximum 10-most painful)

Total opioid consumption intraoperative

时间窗: 48 hours

Measure by total dose consumed (in milligram)

Total opioid consumption post-operative

时间窗: up to 72 hours

Measure by total dose consumed (in milligram)

Timing of first rescue dose of iv morphine

时间窗: up to 24 hours

Post operation till time requiring first dose of iv morphine

次要结局

  • The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation(24 hours)
  • Length of hospital stays(up to 1 week)
  • Time to ambulation after surgery(up to 1 week)
  • Hemodynamic changes intraoperative(Intraoperative period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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