Status:
UNKNOWN
QSPainRelief-patientCNS : Clinical Biomarkers of Nociception, Sedation and Cognition
Lead Sponsor:
Université Catholique de Louvain
Collaborating Sponsors:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Post-operative Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
QSPainRelief-patientCNS is a monocentric prospective longitudinal study conducted in patients suffering from disabling post-surgical pain for which the treating physician is about to prescribe a given...
Detailed Description
QSPainRelief-patientCNS is one of three clinical studies that will be conducted as part of the QSPainRelief project funded by the European Union's Horizon 2020 research and innovation program (grant a...
Eligibility Criteria
Inclusion
- Aged 18-75 years.
- Presence of disabling post-operative pain for more than two weeks following thoracotomy, sternotomy or breast cancer surgery.
- Current treatment of their post-operative pain with an opioid analgesic (along with possible other drugs).
- Decision by the treating physician to introduce an additional non-opioid treatment for their post-operative pain such as (but not necessarily) an antiepileptic or an anti-depressant.
- Capacity to understand and voluntarily sign an informed consent form.
Exclusion
- Insufficient French language skills.
- Planned chemotherapy, hormonotherapy or radiotherapy during the time interval between Visits 1 and 2.
- Clinically evident psychiatric disease that is likely to interfere with the study, according to judgment by the investigator.
- History of peripheral or central nervous system disease before the surgical intervention.
- Dermatological condition involving the sensory testing areas.
- Severe alcohol use disorder (as defined in DSM-5).
- Severe sedative, hypnotic of anxiolytic-related use disorder (as defined in DSM-5).
- Any other mild, moderate or severe substance use disorder except tobacco and caffeine (as defined in DSM-5).
- Consumption of recreational drugs, including cannabis, in the last 4 weeks prior to the study.
- Signs of polyneuropathy at clinical examination.
- Signs of a neurological deficit due to a CNS lesion or dysfunction at clinical examination.
- Any other reason to exclude the subject because it may interfere with the study, according to judgment by the investigator. The reason will be documented.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04742790
Start Date
March 15 2021
End Date
September 30 2024
Last Update
February 8 2021
Active Locations (1)
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1
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200