Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- BDNF level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
BDNF level
Time Frame: preoperative to 6 months after surgery
assessed by ELISA technique
Secondary Outcomes
- Health related quality of life(preoperative to 6 months after surgery)
- 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)
- Pain level perception(preoperative to 6 months after surgery)
- Anxiety and Depression(preoperative to 6 months after surgery)
- Assessment of functional capacities in knee arthritis(preoperative to 6 months after surgery)
- Oxidative stress marker(preoperative to 6 months after surgery)