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临床试验/NCT02924519
NCT02924519Unknown不适用

Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

University of Aarhus0 个研究点目标入组 150 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Acute postoperative pain

研究概览

简要总结

Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the general population and in 21% of the elderly population.

Of particular interest is prediction of postoperative pain after outpatient arthroscopic shoulder surgery since the clinical experience is that surgery does not always provides pain relief and the interindividual variation in acute postoperative pain intensity is significant. In addition, a Swedish study has shown that shoulder operations are associated with longer convalescence than other orthopaedic outpatient surgeries.

详细描述

This study is a prospective cohort with 6 months follow-up. Patients receive 5 questionnaires (preoperatively, 24 hours, 1 week, 3 months, 6 months, 1 and 2 years after surgery). The questionnaires contain questions about:

  • Preoperative shoulder pain (type, intensity and duration)

  • Preoperative pain in other areas besides the shoulder

  • Brief Pain Inventory (BPI)

  • Western Ontario Rotator Cuff Index (WORC)

  • Single Assessment Numeric Evaluation (SANE)

  • 3 validated physiological questionnaires:

  • State Trait Anxiety (STAI)

  • Pain Catastrophizing Scale (PCS)

  • Hospital Anxiety and Depression Scale (HADS)

In addition a cold pressor test is performed on the day of surgery to test the patients' threshold and ability to repress 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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection).

排除标准

  • • < 18 years
  • mental disorders
  • Unable to speak and/or read Danish
  • Shoulder surgery within the last year
  • Raynauds phenomenon
  • Cuff suture
  • Biceps tenodesis
  • Labrum suture

结局指标

主要结局

Acute postoperative pain

时间窗: 24 hours after surgery

Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS\>3= acute postoperative pain

Chronic postoperative pain

时间窗: 6 months after surgery

Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. Chronic postoperative pain is defined as NRS\>=3 with an impact on daily living

次要结局

  • Preoperative psychological predictors for chronic pain(6 months after surgery)
  • Acute postoperative pain(3 month after surgery)
  • Preoperative comorbidity(6 months after surgery)
  • Preoperative physical predictors for chronic pain(6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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