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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04604847
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
200
1
1
45.9
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: blood test
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
Actual Study Start Date :
Dec 4, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Total knee arthroplasty

patient operated for a total knee arthroplasty

Diagnostic Test: blood test
blood test to explore BDNF level

Outcome Measures

Primary Outcome Measures

  1. BDNF level [preoperative to 6 months after surgery]

    assessed by ELISA technique

Secondary Outcome Measures

  1. Pain level [preoperative to 6 months after surgery]

    evaluated by Visual Analog Scale (VAS)

  2. Neuropathic pain diagnostic [preoperative to 6 months after surgery]

    evaluated by neuropathic pain diagnostic questionnaire (DN4)

  3. Postoperative rehabilitation [preoperative to 6 months after surgery]

    evaluated by the Brief Pain Questionary (BPI)

  4. Health related quality of life [preoperative to 6 months after surgery]

    evaluated by the SF-12 Health Survey

  5. Anxiety and Depression [preoperative to 6 months after surgery]

    evaluated by the Hospital Anxiety and Depression scale (HAD)

  6. Pain level perception [preoperative to 6 months after surgery]

    evaluated by the The pain Catastrophizing Scale

  7. Assessment of functional capacities in knee arthritis [preoperative to 6 months after surgery]

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

  8. Oxidative stress marker [preoperative to 6 months after surgery]

    8-iso-prostaglandin F2α level by biochemical labeling

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and critical care, Lapeyronie University Hospital Montpellier France 34295

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04604847
Other Study ID Numbers:
  • RECHMPL19_0192
First Posted:
Oct 27, 2020
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 15, 2021