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Central Sensitisation and Postoperative Pain

Primary Purpose

Thoracotomy, Hyperalgesia, Hyperalgesia, Secondary

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
electroencephalography (EEG)
questionnaires
high frequency electrical stimulation of the forearm skin (HFS)
cutaneous mechanical pinprick stimulation
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Thoracotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery
  • Saint Luc HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients undergo lateral thoracotomy for primary lung cancer

Arm Description

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

Outcomes

Primary Outcome Measures

mechanical pinprick perceived intensity
magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
area of increased mechanical pinprick sensitivity
spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS
resting state EEG
frequency content of the resting state EEG

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
October 5, 2021
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04220697
Brief Title
Central Sensitisation and Postoperative Pain
Official Title
Behavioural and Neurophysiological Measurements for the Assessment of Central Sensitisation and Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracotomy, Hyperalgesia, Hyperalgesia, Secondary, Central Sensitisation, Electroencephalography, Persistent Postsurgical Pain, Humans

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients undergo lateral thoracotomy for primary lung cancer
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
electroencephalography (EEG)
Intervention Description
recording of resting state EEG using 64 surface electrodes
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Description
Hospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS)
Intervention Type
Other
Intervention Name(s)
high frequency electrical stimulation of the forearm skin (HFS)
Intervention Description
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
Intervention Name(s)
cutaneous mechanical pinprick stimulation
Intervention Description
Mechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN).
Primary Outcome Measure Information:
Title
mechanical pinprick perceived intensity
Description
magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
Time Frame
1 day before surgery
Title
area of increased mechanical pinprick sensitivity
Description
spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS
Time Frame
1 day before surgery
Title
resting state EEG
Description
frequency content of the resting state EEG
Time Frame
1 week before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuel van den Broeke, PhD
Phone
003227645467
Email
emanuel.vandenbroeke@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric Lenoir, PhD
Phone
003227645467
Email
cedric.lenoir@@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Lacroix, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Lacroix, MD, PhD
Phone
003227646107
Email
valerie.lacroix@uclouvain.be
Facility Name
Saint Luc Hospital
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Lacroix, Prof.
Phone
003227646106
Email
valerie.lacroix@saintluc.uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Central Sensitisation and Postoperative Pain

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