Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics

NCT ID: NCT04604847

Last Updated: 2024-06-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-04

Study Completion Date

2024-03-19

Brief Summary

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Chronic pain is an extremely disabling disease. It is a major public health problem due to the lack of effective therapy.

Chronic postoperative pain (CPOP) is defined by a painful symptomatology in the operated area unrelated to previous pain, present for more than 3 months, and without any link to surgical complication.

The prevalence of chronicization of postoperative pain is 30% after total knee arthroplasty.

Identification of clinical, biological and psychological profiles are crucial to prevent CPOP.

A biologic factor, Brain Derived Neurotrophic Factor (BDNF) produced by a variety of cells is a key regulator of neuroplasticity. BDNF is increasingly studied in the mechanisms of cerebral sensitization and pain chronicization. The role of BDNF in pain of patients remains to be explored in a prospective study. The aim of this observational study is to compare the kinetics of BDNF after total knee arthroplasty in patients with and without CPOP.

Patients will be included in the study at the preanesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.

Detailed Description

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Conditions

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Total Knee Arthroplasty Chronic Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective study to analyze perioperative blood samples in patient after knee replacement surgery. Patients will be included in the study at the pre-anesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Total knee arthroplasty

patient operated for a total knee arthroplasty

Group Type OTHER

blood test

Intervention Type DIAGNOSTIC_TEST

blood test to explore BDNF level

Interventions

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blood test

blood test to explore BDNF level

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Social security affiliation
* Adult patients
* Signed informed consent
* Score ASA (American Society of Anesthesiology) 1-3
* Total knee arthroplasty

Exclusion Criteria

* Patient unable to exercise consent
* Pregnant women
* Vulnerable people
* Patients not included in the postoperative rehabilitation program
* Patients unable to complete the pain assessment questionnaires
* Chronic pain patients (other than knee arthrosis)
* Neuropathic pain patients (beforehand)
* Inflammatory diseases, progressive cancer, sepsis, immunosuppression known
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL19_0192

Identifier Type: -

Identifier Source: org_study_id

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