Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

• Conditions: Chronic Postoperative Pain

• Registration Number: NCT02924519
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2014-05
• Status Verified: 2016-08
• Study First Submitted: 2016-08-09
• Primary Completion: 2016-10
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-05
• Last Update Posted: 2016-10-05
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute postoperative pain	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	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 Outcome Measures

Name	Time	Method
Preoperative psychological predictors for chronic pain	6 months after surgery	Pain Catastrophizing Scale (PCS)
Acute postoperative pain	3 month after surgery	Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS\>3= acute postoperative pain
Preoperative comorbidity	6 months after surgery	Other places than the shoulder
Preoperative physical predictors for chronic pain	6 months after surgery	Cold pressure test