Central Sensitisation and Postoperative Pain

NCT ID: NCT04220697

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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patients undergo lateral thoracotomy for primary lung cancer

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

Group Type EXPERIMENTAL

electroencephalography (EEG)

Intervention Type OTHER

recording of resting state EEG using 64 surface electrodes

questionnaires

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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electroencephalography (EEG)

recording of resting state EEG using 64 surface electrodes

Intervention Type OTHER

questionnaires

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

Intervention Type 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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie Lacroix, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Department of Surgery

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Saint Luc Hospital

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Emanuel van den Broeke, PhD

Role: CONTACT

003227645467

Cédric Lenoir, PhD

Role: CONTACT

Facility Contacts

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Valérie Lacroix, MD, PhD

Role: primary

003227646107

Valérie Lacroix, Prof.

Role: primary

003227646106

Other Identifiers

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POSTOP pain

Identifier Type: -

Identifier Source: org_study_id

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