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临床试验/NCT05264012
NCT05264012已完成不适用

Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery

National Institute of Mental Health and Neuro Sciences, India1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Postoperative pain using Numerical Rating Scale

研究概览

简要总结

The proposed study intends to evaluate incidence of postoperative pain after neurosurgery. This study is likely to help in understanding of the magnitude of this problem in our country and inform about possible predictors which will help institute pre-emptive interventions to mitigate modifiable risk factors of pain after neurosurgery.

详细描述

Data regarding potential risk factors for postoperative pain will be collected. Preoperative factors (preoperative pain, anxiety or depression, perception about surgery, age, gender, socio-economic status, educational level, domicile location, obesity, surgical site [infratentorial or supratentorial or cervical, thoracic or lumbar], use of steroids and analgesics), and intraoperative factors (scalp/ESP/caudal block, incision site infiltration, dose of analgesics such as opioids, paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs), co-analgesics such as nitrous oxide, gabapentionoids, dexmedetomidine, magnesium or lignocaine infusion, anti-epileptics, steroids, minimum alveolar concentration (MAC) of inhalational anesthetics, and duration of surgery and anesthesia) that are likely to be associated with occurrence of postoperative pain will be explored along with relationship between acute and persistent postoperative pain and between intraoperative nociception 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

入选标准

  • all eligible consecutive consenting adult patients aged > 18 years with preoperative Glasgow Coma Scale (GCS) score of 15 undergoing elective craniotomies and spine surgeries

排除标准

  • children, patients with GCS < 15, patients not extubated within 2 hours of end of anesthesia and those who not able to respond to our questions on outcomes

结局指标

主要结局

Postoperative pain using Numerical Rating Scale

时间窗: on days 1-3 after surgery

Acute postoperative pain

次要结局

  • patient satisfaction using Likert scale 1-5(Day 2 after surgery)
  • Persistent postoperative pain using Numerical Rating Scale (NRS)(3 and 6 months after surgery)
  • postoperative sleep quality using Likert 1-5 scale(Day 2 after surgery)
  • duration of postoperative hospital stay in days(through hospital stay, an average of 10 days)

研究者

发起方
National Institute of Mental Health and Neuro Sciences, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sriganesh Kamath

Principal Investigator

National Institute of Mental Health and Neuro Sciences, India

研究点 (1)

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