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Completed

NCT Number: NCT02960971

Neuropathic Pain After Lung Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Pain Research Center, Aarhus University Hospital, Aarhus C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracic surgery for lung cancer

Procedure

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.

Primary outcomes

  1. Chronic Neuropathic Pain, Postoperative

    Time frame: 12 months after surgery

    Neuropathic pain grading system, Finnerup et al. 2016 will be used.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Aarhus University Hospital
  • DOLORisk Consortium

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Nov 10, 2016
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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