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Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.
Background
Severe acute pain as well as long-lasting pain after surgery and pain-related interference of daily activities are frequent. Some risk factors for severe pain after surgery in adults have been described, e.g. younger age and pre-existing chronic pain. The question arises whether a specific genetic background is related to an unfavorable pain outcome.
Objective
The aim of this study is to investigate clinical and genetic variables and their possible association to severe acute postoperative pain, higher analgesic consumption and the development of chronic postsurgical pain.
Methods
Prospective observational study investigating clinical, patient related, surgery related and anesthesia related variables as well as genetic variants and their possible association to patients' pain related outcome after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Patients undergoing elective surgery with anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain related impairment after surgery and its association to genetic and non-genetic variables | Measured by the International Pain Outcomes Questionnaire, the Brief Pain Inventory (BPI): Numeric rating scale for pain intensities, affective and physical interference; Composite score = pain interference total scores (PITS scale 0-10) resulting in no interference (PITS=0), mild interference (PITS >0 and <2), moderate interference (PITS 2-5) and severe interference (PITS >5) | day of surgery up to 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Association of genetic and non-genetic variables with analgesic consumption | analgesic consumption | day of surgery up to one year after surgery |
| Association of genetic and non-genetic variables with pain related outcome of patients 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria
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Adult patients scheduled for elective surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulrike M Stamer, Prof. MD | Contact | 0041-316329995 | ulrike.stamer@dbmr.unibe.ch | |
| Frank Stüber, Prof. MD | Contact | 0041-316322483 | frank.stueber@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Ulrike Stamer, Prof. MD | Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern | Study Chair |
| Ulrike M Stamer, MD | Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern | Recruiting | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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whole blood (plasma and cells) or mucosal swab
Measured by the Brief Pain Inventory (BPI) as pain interference total score PITS scale 0-10) resulting in no interference (PITS=0), mild interference (PITS >0 and <2), moderate interference (PITS 2-5) and severe interference (PITS >5). Change of pain related impairment over time (before surgery, 2 days after surgery, 6 and 12 months after surgery) |
| Up to one year after surgery |
| Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain | Measured by a neuropathic pain questionnaire (number of neuropathic symptoms; at least three neuropathic symptoms are categorized as positive) | up to one year after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |