Clinical trial NCT04604847: Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
Official title: Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Chronic Postoperative Pain
Keywords: Chronic Postoperative Pain
Brain Derived Neurotrophic Factor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: BDNF level
timeFrame: preoperative to 6 months after surgery
Secondary outcomes:
measure: Pain level
timeFrame: preoperative to 6 months after surgery
measure: Neuropathic pain diagnostic
timeFrame: preoperative to 6 months after surgery
measure: Postoperative rehabilitation
timeFrame: preoperative to 6 months after surgery
measure: Health related quality of life
timeFrame: preoperative to 6 months after surgery
measure: Anxiety and Depression
timeFrame: preoperative to 6 months after surgery
measure: Pain level perception
timeFrame: preoperative to 6 months after surgery
measure: Assessment of functional capacities in knee arthritis
timeFrame: preoperative to 6 months after surgery
measure: Oxidative stress marker
timeFrame: preoperative to 6 months after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital
Study officials:
References: