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Central Sensitisation and Postoperative Pain

Behavioural and Neurophysiological Measurements for the Assessment of Central Sensitisation and Postoperative Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04220697
Enrollment
70
Registered
2020-01-07
Start date
2020-01-29
Completion date
2022-12-31
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sensitisation, Electroencephalography, Humans, Hyperalgesia, Hyperalgesia, Secondary, Persistent Postsurgical Pain, Thoracotomy

Brief summary

One out of 10 patients undergoing surgery develops persistent post-surgical pain (PPSP). Unfortunately, available therapies for treating this pain have limited success. It is therefore of great importance to find strategies to prevent PPSP. The goal of this project is to find new screening tools that identify patients that are at risk for developing PPSP. 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.

Interventions

OTHERelectroencephalography (EEG)

recording of resting state EEG using 64 surface electrodes

OTHERquestionnaires

Hospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS)

OTHERhigh 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.

OTHERcutaneous mechanical pinprick stimulation

Mechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN).

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Scheduled for a lateral thoracotomy as treatment for primary lung cancer * Ability to provide written informed consent

Exclusion criteria

* Evidence for a clinically-significant alteration of the skin of the volar forearms * Pregnancy * Having a pacemaker or implanted cardiac defibrillator

Design outcomes

Primary

MeasureTime frameDescription
mechanical pinprick perceived intensity1 day before surgerymagnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
area of increased mechanical pinprick sensitivity1 day before surgeryspatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS
resting state EEG1 week before surgeryfrequency content of the resting state EEG

Countries

Belgium

Contacts

Primary ContactEmanuel van den Broeke, PhD
emanuel.vandenbroeke@uclouvain.be003227645467
Backup ContactCédric Lenoir, PhD
cedric.lenoir@@uclouvain.be003227645467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026