Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuropathic Pain After Lung Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 8, 2016
First Posted Date November 10, 2016
Last Update Posted Date July 13, 2018
Actual Study Start Date January 2, 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2016)
Chronic Neuropathic Pain, Postoperative [ Time Frame: 12 months after surgery ]
Neuropathic pain grading system, Finnerup et al. 2016 will be used.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02960971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 30, 2017)
  • Chronic Chemotherapy-induced Peripheral Neuropathy [ Time Frame: 12 months after surgery ]
    For case definition of neuropathy, Tesfaye et al. 2010 will be used.
  • Chronic Chemotherapy-induced Neuropathic Pain [ Time Frame: 12 months after surgery ]
    Neuropathic pain grading system, Finnerup et al. 2016 will be used.
  • Acute Postoperative Pain [ Time Frame: 0-5 days after surgery ]
    Rest and movement-evoked postoperative pain measured on an 11-point NRS
  • 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
Original Secondary Outcome Measures
 (submitted: November 8, 2016)
  • Chronic Chemotherapy-induced Peripheral Neuropathy [ Time Frame: 12 months after surgery ]
    For case definition of neuropathy, Tesfaye et al. 2010 will be used.
  • Chronic Chemotherapy-induced Neuropathic Pain [ Time Frame: 12 months after surgery ]
    Neuropathic pain grading system, Finnerup et al. 2016 will be used.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuropathic Pain After Lung Surgery
Official Title DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Lung Surgery
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Probability Sample
Study Population Patients scheduled for lung cancer resection at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
Condition
  • Chronic Neuropathic Pain, Postoperative
  • Chronic Pain, Postoperative
  • Chronic Chemotherapy-induced Neuropathic Pain
  • Chronic Chemotherapy-induced Pain
  • Chronic Chemotherapy-induced Peripheral Neuropathy
Intervention 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 12, 2018)
78
Original Estimated Enrollment
 (submitted: November 8, 2016)
275
Estimated Study Completion Date November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02960971
Other Study ID Numbers DOLORISK-LUNG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Danish Pain Research Center
Study Sponsor Danish Pain Research Center
Collaborators
  • DOLORisk Consortium
  • Aarhus University Hospital
Investigators
Study Director: Nanna B Finnerup, DMSc Danish Pain Research Center, Aarhus University
PRS Account Danish Pain Research Center
Verification Date July 2018