Central Sensitisation and Postoperative Pain

Hyperalgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220697
• Other study ID #: POSTOP pain
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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