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Clinical Trials/NCT02924519
NCT02924519
Unknown
Not Applicable

Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

University of Aarhus0 sites150 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Postoperative Pain
Sponsor
University of Aarhus
Enrollment
150
Primary Endpoint
Acute postoperative pain
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
October 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • • \< 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

Outcomes

Primary Outcomes

Acute postoperative pain

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

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