Central Sensitisation and Postoperative Pain

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT04220697
Collaborator
(none)
70
2
1
35.1
35
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: electroencephalography (EEG)
  • Other: questionnaires
  • Other: high frequency electrical stimulation of the forearm skin (HFS)
  • Other: cutaneous mechanical pinprick stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Behavioural and Neurophysiological Measurements for the Assessment of Central Sensitisation and Postoperative Pain
Actual Study Start Date :
Jan 29, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. mechanical pinprick perceived intensity [1 day before surgery]

    magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS

  2. area of increased mechanical pinprick sensitivity [1 day before surgery]

    spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS

  3. resting state EEG [1 week before surgery]

    frequency content of the resting state EEG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Surgery Brussels Belgium 1200
2 Saint Luc Hospital Brussels Belgium 1200

Sponsors and Collaborators

  • Université Catholique de Louvain

Investigators

  • Principal Investigator: Valérie Lacroix, MD, PhD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT04220697
Other Study ID Numbers:
  • POSTOP pain
First Posted:
Jan 7, 2020
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021