Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT02924519

Collaborator

Horsens Regional Hospital (Other)

150

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Postoperative Pain

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Oct 1, 2018

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

Acute postoperative pain [1 week after surgery]
Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain
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 psychological predictors for chronic pain [6 months after surgery]
Hospital Anxiety and Depression Scale (HADS)
Preoperative psychological predictors for chronic pain [6 months after surgery]
State-Trait Anxiety
Preoperative psychological predictors for chronic pain [6 months after surgery]
Pain Catastrophizing Scale (PCS)
Preoperative physical predictors for chronic pain [6 months after surgery]
Cold pressure test
Preoperative comorbidity [6 months after surgery]
Other places than the shoulder

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Aarhus
Horsens Regional Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT02924519

Other Study ID Numbers:

1-10-72-103-14

First Posted:

Oct 5, 2016

Last Update Posted:

Oct 5, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Oct 5, 2016