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Chronic Neuropathic Pain, PostoperativeNCT02960971

Neuropathic Pain After Lung Surgery

An observational study of Chronic Neuropathic Pain, Postoperative and Chronic Pain, Postoperative, run by Danish Pain Research Center at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Thoracic surgery for lung cancer
Type of treatment
Surgery or procedure
How many people
78 participants
Where
2 sitesDenmark
Study dates
2 Jan 2017to 16 Jun 2021
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for lung cancer resection at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Danish Pain Research Center, Aarhus University Hospital

    Aarhus C, 8000

  • Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

    Aarhus N, 8200

Other trials in Denmark

About this study

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

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

Read the 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.

Being tested
Thoracic surgery for lung cancer
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic surgery for lung cancerProcedure or surgery

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic Neuropathic Pain, Postoperative

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

    Measured: 12 months after surgery

Secondary outcomes (4)

  1. Chronic Chemotherapy-induced Peripheral Neuropathy

    For case definition of neuropathy, Tesfaye et al. 2010 will be used.

    Measured: 12 months after surgery

  2. Chronic Chemotherapy-induced Neuropathic Pain

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

    Measured: 12 months after surgery

  3. Acute Postoperative Pain

    Rest and movement-evoked postoperative pain measured on an 11-point NRS

    Measured: 0-5 days after surgery

  4. Area of peri-incisional hyperalgesia

    Quantification of peri-incisional hyperalgesia - area and worst pin-prick pain intensity is assessed with a 5.88 monofilament

    Measured: 0-5 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2016 (estimated)
  2. Study start2 Jan 2017
  3. Primary completion18 Jun 2019
  4. Study completion16 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960971
Sponsor's protocol ID
DOLORISK-LUNG
Status last verified
Feb 2023
First submitted
8 Nov 2016
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

    PubMed 20876709

  • Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.

    PubMed 27115670

  • Sperandio G, Baudic S, Bennedsgaard K, Grosen K, Andersen IS, Finnerup NB, Albi-Feldzer A, Flor H, Nees F, Bouhassira D, Attal N. Somatic and psychological predictors of chronic postsurgical pain in cancer patients: a machine learning approach in a longitudinal two-centre study. Br J Anaesth. 2026 Apr;136(4):1330-1340. doi: 10.1016/j.bja.2025.12.002. Epub 2026 Jan 7.

    PubMed 41506969

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Neuropathic Pain, Postoperative and Chronic Pain, Postoperative, run by Danish Pain Research Center at 2 sites in Denmark.

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 6 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: finished, as of the sponsor's last update on 27 Feb 2023. 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 Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic Neuropathic Pain, Postoperative (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02960971, which also lists 3 linked publications.

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 27 Feb 2023.

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