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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Chronic Postoperative Pain
• Intervention / Treatment: Diagnostic test: blood test

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Department of Anesthesiology and critical care, Lapeyronie University Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Total knee arthroplasty; patient operated for a total knee arthroplasty	Diagnostic test: blood test; blood test to explore BDNF level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BDNF level	assessed by ELISA technique	preoperative to 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	evaluated by Visual Analog Scale (VAS)	preoperative to 6 months after surgery
Neuropathic pain diagnostic	evaluated by neuropathic pain diagnostic questionnaire (DN4)	preoperative to 6 months after surgery
Postoperative rehabilitation	evaluated by the Brief Pain Questionary (BPI)	preoperative to 6 months after surgery
Health related quality of life	evaluated by the SF-12 Health Survey	preoperative to 6 months after surgery
Anxiety and Depression	evaluated by the Hospital Anxiety and Depression scale (HAD)	preoperative to 6 months after surgery
Pain level perception	evaluated by the The pain Catastrophizing Scale	preoperative to 6 months after surgery
Assessment of functional capacities in knee arthritis	evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)	preoperative to 6 months after surgery
Oxidative stress marker	8-iso-prostaglandin F2α level by biochemical labeling	preoperative to 6 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): March 19, 2024
• Study Completion (Actual): March 19, 2024

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Brain Derived Neurotrophic Factor; Chronic Postoperative Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: RECHMPL19_0192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No