NCT Number: NCT03489499
Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bern, 3010, Switzerland
Location status: Recruiting
Lan Zhang, PhD
CONTACT
Ulrike M Stamer, MD
PRINCIPAL_INVESTIGATOR
Ulrike Stamer, Professor MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: day of surgery up to 1 year after surgery
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)
Time frame: day of surgery up to one year after surgery
analgesic consumption
Time frame: Up to one year after surgery
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)
Time frame: up to one year after surgery
Measured by a neuropathic pain questionnaire (number of neuropathic symptoms; at least three neuropathic symptoms are categorized as positive)
Contact information is provided by the study sponsor or research team.
Frank Stüber, Prof. MD
CONTACT
Ulrike M Stamer, Prof. MD
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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