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Neuropathic Pain After Lung Surgery

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ClinicalTrials.gov Identifier: NCT02960971
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
DOLORisk Consortium
Aarhus University Hospital
Information provided by (Responsible Party):
Danish Pain Research Center

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

Condition or disease Intervention/treatment
Chronic Neuropathic Pain, Postoperative Chronic Pain, Postoperative Chronic Chemotherapy-induced Neuropathic Pain Chronic Chemotherapy-induced Pain Chronic Chemotherapy-induced Peripheral Neuropathy Procedure: Thoracic surgery for lung cancer

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.


Study Design
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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Lung Surgery
Actual Study Start Date : January 2, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Chronic Neuropathic Pain, Postoperative [ Time Frame: 12 months after surgery ]
    Neuropathic pain grading system, Finnerup et al. 2016 will be used.


Secondary Outcome Measures :
  1. Chronic Chemotherapy-induced Peripheral Neuropathy [ Time Frame: 12 months after surgery ]
    For case definition of neuropathy, Tesfaye et al. 2010 will be used.

  2. Chronic Chemotherapy-induced Neuropathic Pain [ Time Frame: 12 months after surgery ]
    Neuropathic pain grading system, Finnerup et al. 2016 will be used.

  3. Acute Postoperative Pain [ Time Frame: 0-5 days after surgery ]
    Rest and movement-evoked postoperative pain measured on an 11-point NRS

  4. Area of peri-incisional hyperalgesia [ Time Frame: 0-5 days after surgery ]
    Quantification of peri-incisional hyperalgesia - area and worst pin-prick pain intensity is assessed with a 5.88 monofilament


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for lung cancer resection at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960971


Locations
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Denmark
Danish Pain Research Center, Aarhus University Hospital
Aarhus C, Denmark, 8000
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Danish Pain Research Center
DOLORisk Consortium
Aarhus University Hospital
Investigators
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Study Director: Nanna B Finnerup, DMSc Danish Pain Research Center, Aarhus University
More Information
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Additional Information:
DOLORISK Consortium Homepage  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT02960971     History of Changes
Other Study ID Numbers: DOLORISK-LUNG
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Chronic Pain
Pain, Postoperative
Pain
Neurologic Manifestations
 Signs and Symptoms
Neuromuscular Diseases
Nervous System Diseases
Postoperative Complications
Pathologic Processes