Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. In this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.
详细描述
Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. On the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. The main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. Secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain
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
- 否
入选标准
- •Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
- •Signed informed consent.
排除标准
- •Mini Mental State Examination with a score less than or equal to 24 points.
- •Patients suffering from disabilities.
- •Patients who can not collaborate in the postoperative clinical assessment.
- •Patients who can not be assessed during the postoperative period by the Acute Pain Unit.
研究组 & 干预措施
Metamizol postoperatively
Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively
干预措施: Metamizole (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 48 hours postoperatively
Using the Visual Analgesic Scale (from 0 to 10, with 0 being the state corresponding to "no pain" and 10 being the "maximum pain imaginable ") and postoperative analgesic satisfaction assessed by the patient (stratified in Bad, Fair, Good or Excellent).
次要结局
- Side effects secondary to metamizol(48 hours postoperatively)
- To assess the correlation between preoperative anxiety and postoperative pain.(From the day before surgery to the second day postoperatively)
研究者
Ángel Becerra
Principal Investigator
Dr. Negrin University Hospital