Central Sensitisation and Postoperative Pain

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emanuel van den Broeke, PhD; Phone Number: 003227645467; Email: emanuel.vandenbroeke@uclouvain.be
• Study Contact Backup: Name: Cédric Lenoir, PhD; Phone Number: 003227645467; Email: cedric.lenoir@@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Not yet recruiting
    • Department of Surgery
    • Contact: Valérie Lacroix, MD, PhD; Phone Number: 003227646107; Email: valerie.lacroix@uclouvain.be
  • Brussels, Belgium, 1200
    • Recruiting
    • Saint Luc Hospital
    • Contact: Valérie Lacroix, Prof.; Phone Number: 003227646106; Email: valerie.lacroix@saintluc.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: patients undergo lateral thoracotomy for primary lung cancer; Electroencephalography (EEG) will be acquired before surgery; Questionnaires assessing psychological status of the patients before and after surgery; High frequency electrical stimulation of the skin (HFS) will be delivered before surgery; Quantification of mechanical sensitivity after HFS and after surgery

Other: electroencephalography (EEG); recording of resting state EEG using 64 surface electrodes; Other: questionnaires; Hospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS); Other: 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.; Other: 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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Valérie Lacroix, MD, PhD, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2020
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Pain, Postoperative; Hyperalgesia
• Other Study ID Numbers: Postop pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No