Clinical trial NCT02924519: Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery
Official title: Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Postoperative Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Horsens
First posted: 2016-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for ambulatory (outpatient) arthroscopic shoulder surgery

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.

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

Primary outcomes:
measure: Chronic postoperative pain
timeFrame: 6 months after surgery
measure: Acute postoperative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Acute postoperative pain
timeFrame: 1 week after surgery
measure: Acute postoperative pain
timeFrame: 3 month after surgery
measure: Preoperative psychological predictors for chronic pain
timeFrame: 6 months after surgery
measure: Preoperative psychological predictors for chronic pain
timeFrame: 6 months after surgery
measure: Preoperative psychological predictors for chronic pain
timeFrame: 6 months after surgery
measure: Preoperative physical predictors for chronic pain
timeFrame: 6 months after surgery
measure: Preoperative comorbidity
timeFrame: 6 months after surgery
Other outcomes:
Locations:
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