Study of Lipid Mediators in Chronic Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Female Postoperative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Chronic pain

Group Type EXPERIMENTAL

Blood sample + questionnaire

Intervention Type OTHER

* blood sample before tumor surgery and at every follow-up visit
* questionnaire before tumor surgery and at every follow-up visit

No chronic pain

Group Type ACTIVE_COMPARATOR

Blood sample + questionnaire

Intervention Type OTHER

* blood sample before tumor surgery and at every follow-up visit
* questionnaire before tumor surgery and at every follow-up visit

Interventions

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Blood sample + questionnaire

* blood sample before tumor surgery and at every follow-up visit
* questionnaire before tumor surgery and at every follow-up visit

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No