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临床试验/NCT01351363
NCT01351363已完成不适用

PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY

NHS Fife2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
NHS Fife
入组人数
43
试验地点
2
主要终点
Post operative pain level

研究概览

简要总结

Following arthroscopic shoulder surgery a small but significant number of people suffer severe postoperative pain.

This study aims to predict which patients are at risk of developing severe post operative pain so that they may be targeted with a more aggressive post operative pain regimen.

详细描述

Patients presenting for elective (day case) arthroscopic shoulder surgery for either Arthroscopic Subacromial Decompression (ASD Group) or Rotator Cuff Repair (RCR Group) are recruited. Using a Cefar PainMatcher, a pain and sensory threshold assessment tool, consenting patients will have their preoperative pain thresholds recorded. The patients will then have a standard anaesthetic administered with TIVA (propofol/remifentanil) and either a subacromial injection (ASD Group) or interscalene block (RCR Group). Four days following surgery a telephone questionnaire will be completed by the patients recording their worst pain score since surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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 able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)

排除标准

  • Unable to give informed consent
  • Allergy to remifentanil, propofol or levobupivacaine.
  • Absence of contralateral arm (thumb/fingers)
  • Documented sensory abnormality (e.g. peripheral neuropathy)
  • Those not consenting to subacromial injection or interscalene block intraopertively (part of routine management after surgery).
  • Psychiatric disease (documented history in Hospital notes or GP referral summary)
  • Drug or alcohol misuse (suspicion of or documented)
  • No telephone or unable to communicate in English (no interpreter service available)

结局指标

主要结局

Post operative pain level

时间窗: 4 days

Post operative pain level recorded on a VAS (0-10) at rest and movement for the first four days pots shoulder surgery. This information will be correlated with the preoperative pain threshold of patients taken with the Pain matcher machine.

次要结局

未报告次要终点

研究者

发起方
NHS Fife
申办方类型
Other Gov

研究点 (2)

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