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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
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This study aims to externally validate two clinical prediction models for moderate-to-severe acute post-surgical pain and chronic post-surgical pain. This multi-centre, prospective cohort study will be conducted in Denmark and will include adult patients undergoing various types of elective or sub-acute surgical procedures.
Based on sample size calculations for prediction model validation, a total of 482 patients are required validation of the acute post-surgical pain model and 748 (575 + 30% for loss to follow-up) patients are required for validation of the chronic post-surgical pain model. Therefore, we will aim to recruit 748 patients in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery patients | Patients undergoing various elective and sub-acute surgical procedures including thoracic, cardiac, abdominal, vascular, plastic, spinal neurosurgery, and orthopaedic procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Moderate-to-severe acute post-surgical pain | Worst pain intensity score at rest ≥ 4 on an 11-point numeric rating scale (NRS; 0-10) in the post-anaesthesia care unit (PACU) following surgery, where 0=no pain and 10=worst pain imaginable. | First 3 postoperative hours or until discharge from the PACU |
| Chronic post-surgical pain | Pain related to the surgical procedure measured as average pain intensity on rest or movement ≥ 3 in the past one week using an 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and average pain interference ≥ 3 using 11-point NRS among any one of seven short-form Brief Pain Inventory items (general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, enjoyment of life) in the past one week, where 0=pain does not interfere and 10=pain completely interferes. | 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Severe acute post-surgical pain | Worst pain intensity score at rest ≥ 7 on an 11-point numeric rating scale (NRS; 0-10) in the post-anaesthesia care unit (PACU) following surgery, where 0=no pain and 10=worst pain imaginable. | First 3 postoperative hours or until discharge from the PACU |
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Inclusion Criteria:
All patients ≥ 18 years undergoing elective or sub-acute surgery
Exclusion Criteria:
Cognitive impairment not allowing for informed consent
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Patients undergoing elective or sub-acute surgery meeting inclusion and exclusion criteria, including thoracic, cardiac, abdominal, vascular, plastic, neurosurgery and orthopaedic surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lone Nikolajsen | Contact | +45 7846 4317 | Lone.nikolajsen@clin.au.dk | |
| Camilla Gaarsdal Uhrbrand | Contact | +45 2395 6082 | Camgaa@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lone Nikolajsen | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Bispebjerg and Frederiksberg Hospital | Completed | Copenhagen | 2400 | Denmark |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |