ThoracotomyNCT04220697
Central Sensitisation and Postoperative Pain
A study testing electroencephalography (EEG), questionnaires and high frequency electrical stimulation of the forearm skin (HFS) in people with Thoracotomy and Hyperalgesia, run by Université Catholique de Louvain at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracotomy, Hyperalgesia, Hyperalgesia, Secondary
- What is being tested?
- electroencephalography (EEG), questionnaires and high frequency electrical stimulation of the forearm skin (HFS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesBelgium
- Study dates
- 29 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for a lateral thoracotomy as treatment for primary lung cancer
- Ability to provide written informed consent
Who cannot join
- Evidence for a clinically-significant alteration of the skin of the volar forearms
- Pregnancy
- Having a pacemaker or implanted cardiac defibrillator
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Department of Surgery
Brussels, 1200
Valérie Lacroix, MD, PhD, 003227646107, valerie.lacroix@uclouvain.be
- Recruiting
Saint Luc Hospital
Brussels, 1200
Valérie Lacroix, Prof., 003227646106, valerie.lacroix@saintluc.uclouvain.be
About this study
Official title: 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.
Read more
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
- Being tested
- electroencephalography (EEG), questionnaires, high frequency electrical stimulation of the forearm skin (HFS), cutaneous mechanical pinprick stimulation
- Medical subject headings
- Hyperalgesia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalography (EEG)Other
recording of resting state EEG using 64 surface electrodes
questionnairesOther
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)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 stimulationOther
Mechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: electroencephalography (EEG); Other: questionnaires; Other: high frequency electrical stimulation of the forearm skin (HFS); Other: cutaneous mechanical pinprick stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical pinprick perceived intensity
magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
Measured: 1 day before surgery
area of increased mechanical pinprick sensitivity
spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS
Measured: 1 day before surgery
resting state EEG
frequency content of the resting state EEG
Measured: 1 week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start29 Jan 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Lacroix, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220697
- Sponsor's protocol ID
- POSTOP pain
- Status last verified
- Oct 2021
- First submitted
- 6 Jan 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural and Neurophysiological Measurements for the Assessment of Central Sensitisation and Postoperative Pain
- ClinicalTrials.gov ID
- NCT04220697
- Acronym / sponsor ID
- POSTOP pain
- Conditions
- Thoracotomy, Hyperalgesia, Hyperalgesia, Secondary, Central Sensitisation, Electroencephalography, Persistent Postsurgical Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergo lateral thoracotomy for primary lung cancer | Experimental | Other: electroencephalography (EEG), Other: questionnaires, Other: high frequency electrical stimulation of the forearm skin (HFS), Other: cutaneous mechanical pinprick stimulation1. 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for a lateral thoracotomy as treatment for primary lung cancer
- Ability to provide written informed consent
Key exclusion criteria (3 listed)
- Evidence for a clinically-significant alteration of the skin of the volar forearms
- Pregnancy
- Having a pacemaker or implanted cardiac defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalography (EEG)recording of resting state EEG using 64 surface electrodes | Other | patients undergo lateral thoracotomy for primary lung cancer |
| questionnairesHospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS) | Other | patients undergo lateral thoracotomy for primary lung cancer |
| 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 | patients undergo lateral thoracotomy for primary lung cancer |
| cutaneous mechanical pinprick stimulationMechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN). | Other | patients undergo lateral thoracotomy for primary lung cancer |
Primary outcome
mechanical pinprick perceived intensity
Time frame: 1 day before surgery
magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
area of increased mechanical pinprick sensitivity
Time frame: 1 day before surgery
spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS
resting state EEG
Time frame: 1 week before surgery
frequency content of the resting state EEG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Lacroix, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography (EEG), questionnaires and high frequency electrical stimulation of the forearm skin (HFS) in people with Thoracotomy and Hyperalgesia, run by Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuel van den Broeke, PhD (003227645467, emanuel.vandenbroeke@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical pinprick perceived intensity (time frame: 1 day before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.