跳至主要内容
临床试验/NCT01662219
NCT01662219已完成不适用

Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.

研究概览

简要总结

Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted as moderate in severity, often needing oral opioid analgesics. In addition, these patients are more prone for postoperative respiratory complication due to airway edema secondary to surgical retraction or wound hematoma. Opioid analgesics provide good pain control but postoperative nausea and vomiting and respiratory depression are undesirable in these patients who are at risk for postoperative wound hematoma and airway edema The use of multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after ambulatory procedures at most surgery centers throughout the world . The purpose of this study is to determine whether superficial cervical plexus block will improve the postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.

详细描述

Anterior cervical discectomy and fusion is increasingly being done as a day surgery or short stay surgery. Postoperative pain is the leading cause of unplanned hospital admissions following day surgery, a major source of dissatisfaction and often impairs the quality of recovery. Opioid analgesics alone are not always effective and may also worsen the postoperative nausea and vomiting and in turn the postoperative recovery. This study is designed to find out if an injection of freezing on the side of neck around the nerves (superficial cervical plexus block) improves the quality of recovery from anesthesia and surgery by reducing the pain, analgesic consumption after anterior cervical spine surgery.

Primary Outcome Measure The primary outcome measure is the global QoR-40 aggregate score at 24 hours after surgery.

Secondary Outcome Measures

  • Postoperative pain scores (first 24 hours)
  • Total analgesic consumption (first 24 hours)
  • Time for first opioid administration
  • Postop Nausea and vomiting (first 24 hours)
  • Post operative sedation (first 24 hours)

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 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 anterior cervical disc surgery in supine position

排除标准

  • In patients who are allergic to local anesthetics
  • ASA- IV patients
  • Lack of informed consent
  • Pregnant patient

研究组 & 干预措施

superficial cervical plexus block

Experimental

superficial cervical plexus block for experimental group

干预措施: Superficial cervical plexus block for experimental group (Other)

No Block

No Intervention

no superficial cervical plexus block for the no intervention group

结局指标

主要结局

The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.

时间窗: 24 hours

次要结局

  • Post operative analgesic consumption(24 hours)
  • post operative nausea and vomiting(24 hrs)
  • post operative sedation score(24 hrs)
  • time for the first dose of opioid consumption(24 hrs)
  • post operative pain score assessment(24 hours)

研究者

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

Lashmi Venkatraghavan

Dr. Lashmikumar Venkatraghavan, Asst. Professor,Dept. of Anesthesia, TWH, UHN,Toronto,ON.

University Health Network, Toronto

研究点 (2)

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