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临床试验/NCT01621555
NCT01621555Unknown不适用

Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery

NHS Fife1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
NHS Fife
入组人数
200
试验地点
1
主要终点
Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.

研究概览

简要总结

The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.

详细描述

Arthroscopic shoulder surgery is increasingly performed on a daycase basis. Optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. However, optimal postoperative pain control in daycase surgery remains a challenge. There is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. Previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. Other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. Recent work has produced a simple questionnaire alternative to pain intensity testing, the Pain Sensitivity Questionnaire (PSQ). We hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome.

The aim of our study is to correlate a patient's pain sensitivity, as measured by the Pain Sensitivity Questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.

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 patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.

排除标准

  • Unable to give informed consent
  • Documented sensory abnormality (e.g. peripheral neuropathy)
  • Contraindication to proposed anaesthetic/analgesic regimen
  • No telephone or unable to communicate in English
  • Documented psychiatric disorder
  • Documented/suspected substance abuse

结局指标

主要结局

Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.

时间窗: 6 months

次要结局

  • The degree of correlation between Pain Sensitivity Questionnaire scores and 'Area Under the Curve (AUC)' for postoperative pain experienced (generated from the VAS scores over 4 postoperative days).(6 months)
  • • The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.(6 months)

研究者

发起方
NHS Fife
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tony Davis

Dr Anthony Davis

NHS Fife

研究点 (1)

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