Study of Lipid Mediators in Chronic Postoperative Pain - LICP

Université Catholique de Louvain

Status: Enrolling

Conditions: Postoperative Pain; Breast Cancer Female

Treatments: Other: Blood sample + questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06907810

LICP

Details and patient eligibility

About

This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.

The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (> 3 months) of postoperative pain after breast cancer surgery.

To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.

To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women older than 18 years
• Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
• Able to give informed consent

Exclusion criteria

• Men
• Women aged less than 18 years
• Pregnant women
• History of major psychiatric disorders
• Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
• Unable to give informed consent

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Chronic pain

Experimental group

Treatment:

Other: Blood sample + questionnaire

No chronic pain

Active Comparator group

Treatment:

Other: Blood sample + questionnaire