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

NCT04604847 | Completed

• 1 other identifier: RECHMPL19_0192
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Chronic Postoperative Pain

Keywords

Chronic Postoperative Pain; Brain Derived Neurotrophic Factor

Outcome Measures

Primary Outcomes (1)

• BDNF level

  assessed by ELISA technique

  preoperative to 6 months after surgery

Secondary Outcomes (8)

• Pain level

  preoperative to 6 months after surgery

• Neuropathic pain diagnostic

  preoperative to 6 months after surgery

• Postoperative rehabilitation

  preoperative to 6 months after surgery

• Health related quality of life

  preoperative to 6 months after surgery

• Anxiety and Depression

  preoperative to 6 months after surgery

Study Arms (1)

Total knee arthroplasty

OTHER

patient operated for a total knee arthroplasty

Diagnostic Test: blood test

Interventions

blood test DIAGNOSTIC_TEST

blood test to explore BDNF level

Total knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 27, 2020
• Study Start: December 4, 2020
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

FR (1)