Neuropathic Pain After Lung Surgery

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neuropathic Pain, Postoperative; Chronic Pain, Postoperative; Chronic Chemotherapy-induced Neuropathic Pain; Chronic Chemotherapy-induced Pain; Chronic Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Danish Pain Research Center, Aarhus University Hospital
  • Aarhus N, Denmark, 8200
    • Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Danish Pain Research Center
• Collaborators: DOLORisk Consortium; Aarhus University Hospital

Publications and helpful links

General 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. Erratum In: Diabetes Care. 2010 Dec;33(12):2725.
• 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.

Helpful Links

• DOLORISK Consortium Homepage

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 10, 2016

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Pain, Postoperative; Chronic Pain; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: DOLORISK-LUNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No