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NCT Number: NCT04604847

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

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.

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Key information

Conditions

Total Knee Arthroplasty Chronic Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Diagnostic Test

blood test to explore BDNF level

Primary outcomes

  1. BDNF level

    Time frame: preoperative to 6 months after surgery

    assessed by ELISA technique

Secondary outcomes

  1. Pain level

    Time frame: preoperative to 6 months after surgery

    evaluated by Visual Analog Scale (VAS)

  2. Neuropathic pain diagnostic

    Time frame: preoperative to 6 months after surgery

    evaluated by neuropathic pain diagnostic questionnaire (DN4)

  3. Postoperative rehabilitation

    Time frame: preoperative to 6 months after surgery

    evaluated by the Brief Pain Questionary (BPI)

  4. Health related quality of life

    Time frame: preoperative to 6 months after surgery

    evaluated by the SF-12 Health Survey

  5. Anxiety and Depression

    Time frame: preoperative to 6 months after surgery

    evaluated by the Hospital Anxiety and Depression scale (HAD)

  6. Pain level perception

    Time frame: preoperative to 6 months after surgery

    evaluated by the The pain Catastrophizing Scale

  7. Assessment of functional capacities in knee arthritis

    Time frame: preoperative to 6 months after surgery

    evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  8. Oxidative stress marker

    Time frame: preoperative to 6 months after surgery

    8-iso-prostaglandin F2α level by biochemical labeling

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Acronym: KNEE BDNF

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2020
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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