Neuropathic Pain After Lung Surgery

Study Overview
=================
Brief Summary
-----------------
To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.

Detailed Description
-----------------
Pain and loss of function are intimately associated with the reaction of the nervous system to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma, metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively impact the individual's quality of life; moreover, the condition leads to significant costs to the healthcare system and society. Not all subjects with such a lesion develop neuropathic pain, and those who do develop neuropathic pain have varying degrees of symptom severity, impact and outcomes and may respond unpredictably to treatment. The interaction between genetics and environmental and clinical factors in a susceptible individual most likely contribute to the variation in pain prevalence and severity. A better understanding of the exact nature of these risk factors and their interactions will ultimately improve the patients' health, both in terms of recognizing patients at risk and identifying new treatment modalities. Genetic, neurophysiological and psychological factors all influence the risk of developing persistent pain. It is therefore possible to describe a genetic, neurophysiological and psychological profile, in particular in patients experiencing neuropathic pain after surgery and/or neurotoxic chemotherapy.

Official Title
-----------------
DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Lung Surgery

Conditions
-----------------
Chronic Chemotherapy-induced Pain, Chronic Neuropathic Pain, Postoperative, Chronic Pain, Postoperative, Chronic Chemotherapy-induced Neuropathic Pain, Chronic Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
-----------------
* Procedure: Thoracic surgery for lung cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects. Age ≥18 years. Patients scheduled for lung cancer resection performed via thoracoscopy and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof. Willingness and ability to comply with study procedures as judged by the site investigator/manager. Expected availability for follow-up throughout the study, i.e.,  12 months. Willingness to voluntarily sign and date the study-specific informed consent form. Exclusion Criteria: Mental incapacity or language barriers precluding adequate understanding of study procedures. Current alcohol or substance abuse according to the site investigator's medical judgement. Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thoracic surgery for lung cancer|Lung cancer resection performed via Video-assisted thoracoscopic surgery (VATS) and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Neuropathic Pain, Postoperative | Neuropathic pain grading system, Finnerup et al. 2016 will be used. | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Chemotherapy-induced Peripheral Neuropathy | For case definition of neuropathy, Tesfaye et al. 2010 will be used. | 12 months after surgery | 
| Chronic Chemotherapy-induced Neuropathic Pain | Neuropathic pain grading system, Finnerup et al. 2016 will be used. | 12 months after surgery | 
| Acute Postoperative Pain | Rest and movement-evoked postoperative pain measured on an 11-point NRS | 0-5 days after surgery | 
| Area of peri-incisional hyperalgesia | Quantification of peri-incisional hyperalgesia - area and worst pin-prick pain intensity is assessed with a 5.88 monofilament | 0-5 days after surgery |