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临床试验/NCT01502540
NCT01502540已完成不适用

Pain Prevalence After Major Craniotomy in Siriraj Hospital

Mahidol University1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
1
主要终点
incidence of moderate to severe pain following major craniotomy

研究概览

简要总结

Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased sympathetic activity and elevated systemic blood pressure. These events in turn may contribute to increased intracranial pressure. Some patients may also develop chronic pain.Potent opioids have been avoided due to its potential to cause respiratory depression and risk of masking pupillary signs. As a result postoperative craniotomy pain controls are usually inadequate.

In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no definite guidelines for postoperative pain management in these patents due to lack of information about quality of postoperative pain control after craniotomy.

Objectives

Primary objective :

  • To study incidence of moderate to severe pain during first 48 hours after craniotomy.

Secondary objectives :

  • To determine risk factors for moderate to severe pain during first 48 hours after craniotomy
  • To evaluate side effects and complications of postoperative craniotomy pain control
  • To compare patient's expectation for pain management before and after surgery
  • To determine patient's satisfaction for postoperative pain management

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery)
  • Age > 18 years

排除标准

  • Emergency or trauma
  • Need postoperative ventilatory support
  • Cannot communication
  • Psychosis
  • Not adherence to the treatment protocol
  • History of using benzodiazepine or addictive substance

结局指标

主要结局

incidence of moderate to severe pain following major craniotomy

时间窗: 48 hours

次要结局

  • risk factors of moderate to severe pain following craniotomy.(48 hours)

研究者

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

Sirilak Suksompong

Associate Professor

Mahidol University

研究点 (1)

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