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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04220697
Other study ID # POSTOP pain
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 29, 2020
Est. completion date December 31, 2022

Study information

Verified date October 2021
Source Université Catholique de Louvain
Contact Emanuel van den Broeke, PhD
Phone 003227645467
Email emanuel.vandenbroeke@uclouvain.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Other:
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).

Locations

Country Name City State
Belgium Department of Surgery Brussels
Belgium Saint Luc Hospital Brussels

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary mechanical pinprick perceived intensity magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS 1 day before surgery
Primary area of increased mechanical pinprick sensitivity spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS 1 day before surgery
Primary resting state EEG frequency content of the resting state EEG 1 week before surgery
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