Central Sensitisation and Postoperative Pain

Not Applicable

• Conditions: Hyperalgesia; Central Sensitisation; Thoracotomy; Hyperalgesia, Secondary; Persistent Postsurgical Pain; Humans; Electroencephalography
• Interventions: Other: electroencephalography (EEG); Other: questionnaires; Other: high frequency electrical stimulation of the forearm skin (HFS); Other: cutaneous mechanical pinprick stimulation

• Registration Number: NCT04220697
• Lead Sponsor: Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-07
• Study Start: 2020-01-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients undergo lateral thoracotomy for primary lung cancer	electroencephalography (EEG)	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
patients undergo lateral thoracotomy for primary lung cancer	high frequency electrical stimulation of the forearm skin (HFS)	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
patients undergo lateral thoracotomy for primary lung cancer	cutaneous mechanical pinprick stimulation	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
patients undergo lateral thoracotomy for primary lung cancer	questionnaires	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

Primary Outcome Measures

Name	Time	Method
mechanical pinprick perceived intensity	1 day before surgery	magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
resting state EEG	1 week before surgery	frequency content of the resting state EEG
area of increased mechanical pinprick sensitivity	1 day before surgery	spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS

Trial Locations

Locations (2)

Department of Surgery; 🇧🇪 Brussels, Belgium

Saint Luc Hospital; 🇧🇪 Brussels, Belgium