Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Sponsors

Lead sponsor: University of Aarhus

Collaborator: Horsens Regional Hospital

Source 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.

Overall Status Unknown status
Start Date May 2014
Completion Date October 2018
Primary Completion Date October 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Chronic postoperative pain 6 months after surgery
Acute postoperative pain 24 hours after surgery
Secondary Outcome
Measure Time Frame
Acute postoperative pain 1 week after surgery
Acute postoperative pain 3 month after surgery
Preoperative psychological predictors for chronic pain 6 months after surgery
Preoperative psychological predictors for chronic pain 6 months after surgery
Preoperative psychological predictors for chronic pain 6 months after surgery
Preoperative physical predictors for chronic pain 6 months after surgery
Preoperative comorbidity 6 months after surgery
Enrollment 150
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: 110 Years

Healthy volunteers: No

Verification Date

August 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov