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

Total Knee Arthroplasty Clinical Trial

— KNEE BDNF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04604847
• Other study ID #: RECHMPL19_0192
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: July 2, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2, 2024
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative
• Total Knee Arthroplasty

Intervention

Diagnostic Test:
• blood test
blood test to explore BDNF level

Locations

Country	Name	City	State
France	Department of Anesthesiology and critical care, Lapeyronie University Hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDNF level	assessed by ELISA technique	preoperative to 6 months after surgery
Secondary	Pain level	evaluated by Visual Analog Scale (VAS)	preoperative to 6 months after surgery
Secondary	Neuropathic pain diagnostic	evaluated by neuropathic pain diagnostic questionnaire (DN4)	preoperative to 6 months after surgery
Secondary	Postoperative rehabilitation	evaluated by the Brief Pain Questionary (BPI)	preoperative to 6 months after surgery
Secondary	Health related quality of life	evaluated by the SF-12 Health Survey	preoperative to 6 months after surgery
Secondary	Anxiety and Depression	evaluated by the Hospital Anxiety and Depression scale (HAD)	preoperative to 6 months after surgery
Secondary	Pain level perception	evaluated by the The pain Catastrophizing Scale	preoperative to 6 months after surgery
Secondary	Assessment of functional capacities in knee arthritis	evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)	preoperative to 6 months after surgery
Secondary	Oxidative stress marker	8-iso-prostaglandin F2a level by biochemical labeling	preoperative to 6 months after surgery