Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Chronic Postoperative Pain Clinical Trial

Official title:

Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02924519
• Other study ID #: 1-10-72-103-14
• Status: Active, not recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: October 3, 2016
• Start date: May 2014
• Est. completion date: October 2018

Study information

• Verified date: August 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Data Protection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 110 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Horsens Regional Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic postoperative pain	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	6 months after surgery	No
Primary	Acute postoperative pain	Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain	24 hours after surgery	No
Secondary	Acute postoperative pain	Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain	1 week after surgery	No
Secondary	Acute postoperative pain	Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain	3 month after surgery	No
Secondary	Preoperative psychological predictors for chronic pain	Hospital Anxiety and Depression Scale (HADS)	6 months after surgery	No
Secondary	Preoperative psychological predictors for chronic pain	State-Trait Anxiety	6 months after surgery	No
Secondary	Preoperative psychological predictors for chronic pain	Pain Catastrophizing Scale (PCS)	6 months after surgery	No
Secondary	Preoperative physical predictors for chronic pain	Cold pressure test	6 months after surgery	No
Secondary	Preoperative comorbidity	Other places than the shoulder	6 months after surgery	No