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临床试验/NCT04646707
NCT04646707招募中不适用

Effect of Erector Spinae (ESP) Block on Opioid Reduction and Enhanced Recovery After Posterior Cervical Spine Surgery

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年2月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Quality of Recovery 40 Questionnaire

研究概览

简要总结

Patients undergoing spine surgery frequently experience significant pain after surgery. This can limit patient activity and hinder rehabilitation. If inadequately treated, severe pain can result in emotional and psychological distress and ultimately impact long-term function, and increase the risk of developing pain that lasts longer than six months associated with depression, anxiety and disability.

More specifically, Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

详细描述

Patients undergoing spine surgery frequently experience significant pain after surgery. Currently, standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.

Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal 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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients aged 18-80 years with ASA class I - III undergoing posterior cervical (C3-T2) decompression and instrumented fusion for cervical stenosis in prone position.

排除标准

  • In patients who are allergic to local anesthetics.
  • ASA IV patients
  • Lack of informed consent
  • Pregnant patient.
  • Fracture cervical spine
  • Extradural or intradural cervical tumors
  • Surgery of C1 and C2 spine

研究组 & 干预措施

Study group

Experimental

Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)

干预措施: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine (Drug)

Placebo Group

Placebo Comparator

Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline

干预措施: Erector Spinae (ESP) Block with placebo (Drug)

结局指标

主要结局

Quality of Recovery 40 Questionnaire

时间窗: 24 hours after surgery.

the global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)

次要结局

  • Postoperative pain(2 weeks and one month)
  • Opioids consumption(2 weeks and one month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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