Central Sensitisation and Postoperative Pain

NCT04220697 | Unknown

• 1 other identifier: POSTOP pain
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

patients undergo lateral thoracotomy for primary lung cancer

EXPERIMENTAL

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

Other: electroencephalography (EEG); Other: questionnaires; Other: high frequency electrical stimulation of the forearm skin (HFS); Other: cutaneous mechanical pinprick stimulation

Interventions

electroencephalography (EEG) OTHER

recording of resting state EEG using 64 surface electrodes

patients undergo lateral thoracotomy for primary lung cancer

questionnaires OTHER

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

patients undergo lateral thoracotomy for primary lung cancer

high frequency electrical stimulation of the forearm skin (HFS) 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.

patients undergo lateral thoracotomy for primary lung cancer

cutaneous mechanical pinprick stimulation OTHER

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

patients undergo lateral thoracotomy for primary lung cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for a lateral thoracotomy as treatment for primary lung cancer
• Ability to provide written informed consent

You may not qualify if:

• Evidence for a clinically-significant alteration of the skin of the volar forearms
• Pregnancy
• Having a pacemaker or implanted cardiac defibrillator

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (2)

Department of Surgery

Brussels, 1200, Belgium

NOT YET RECRUITING

Saint Luc Hospital

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Hyperalgesia; Pain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Valérie Lacroix, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuel van den Broeke, PhD

CONTACT

003227645467; emanuel.vandenbroeke@uclouvain.be

Cédric Lenoir, PhD

CONTACT

003227645467; cedric.lenoir@@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 7, 2020
• Study Start: January 29, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)