Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2020-01-29
2022-12-31
Brief Summary
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Tissue injury and inflammation following surgery increase the excitability of spinal nociceptive neurons ("central sensitisation", CS) with pain hypersensitivity as consequence. It is thought that CS plays an important role in persistent pain.
The first objective of this project is to assess in human patients if the propensity to develop CS manifested as secondary hyperalgesia before surgery is predictive for PPSP.
In addition, we will test if the frequency content of the resting-state EEG reflecting the initial state of the brain will be related to the propensity for developing CS and to the presence of PPSP at two months after surgery.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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patients undergo lateral thoracotomy for primary lung cancer
1. Electroencephalography (EEG) will be acquired before surgery
2. Questionnaires assessing psychological status of the patients before and after surgery
3. High frequency electrical stimulation of the skin (HFS) will be delivered before surgery
4. Quantification of mechanical sensitivity after HFS and after surgery
electroencephalography (EEG)
recording of resting state EEG using 64 surface electrodes
questionnaires
Hospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS)
high frequency electrical stimulation of the forearm skin (HFS)
HFS consists of transcutaneous electrical stimuli delivered as 42 Hz trains (pulse width: 2 ms) lasting 1 s. The trains are repeated 12 times. Each train is separated by 10 seconds.
cutaneous mechanical pinprick stimulation
Mechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN).
Interventions
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electroencephalography (EEG)
recording of resting state EEG using 64 surface electrodes
questionnaires
Hospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS)
high frequency electrical stimulation of the forearm skin (HFS)
HFS consists of transcutaneous electrical stimuli delivered as 42 Hz trains (pulse width: 2 ms) lasting 1 s. The trains are repeated 12 times. Each train is separated by 10 seconds.
cutaneous mechanical pinprick stimulation
Mechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN).
Eligibility Criteria
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Inclusion Criteria
* Ability to provide written informed consent
Exclusion Criteria
* Pregnancy
* Having a pacemaker or implanted cardiac defibrillator
18 Years
80 Years
ALL
No
Sponsors
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Université Catholique de Louvain
OTHER
Responsible Party
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Principal Investigators
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Valérie Lacroix, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Locations
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Department of Surgery
Brussels, , Belgium
Saint Luc Hospital
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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POSTOP pain
Identifier Type: -
Identifier Source: org_study_id
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