Chronic Postsurgical Pain, Neuropathic Pain
Conditions
Keywords
Neuropathic pain, Chronic postsurgical pain prevention, Intraoperative platelet rich fibrin, Disc herniation surgery
Brief summary
The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.
Detailed description
A superiority study, phase III, prospective, single-center, randomized in parallel groups and conducted in a single-blind manner, with evaluation by a blind outcome assessor. Patients will be randomized to one of two treatment groups: Experimental group (surgery and periradicular administration of PRF) or Control group (reference treatment, surgery alone).
Interventions
BIOLOGICALTreatment
Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient, male or female, \>18 years old at the time of signing informed consent; * Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery department; * Patient affiliated to a social security health insurance scheme; * Patient able to understand the objectives and risks of research and to give informed, dated and signed consent; * Patient having been informed of the results of the prior medical examination; * Women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study.
Exclusion criteria
* Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar); * Patient with HIV, active cancer, HBV, HCV (verified by interview); * Patient on long-term systemic corticosteroid therapy; * Patient with an ASA score \> 3 during the consultation with the anesthesiologist; * Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding); * Patient in exclusion period (determined by a previous or ongoing study); * Subject under safeguard of justice; * Subject under curatorship; * Pregnancy; * Breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the effectiveness of periricular intraoperative application of Platelet- and Fibrin-enriched plasma (PRF) on the intensity of residual neuropathic pain postoperatively with primary herniated disc surgery. | 6 months | Average intensity, over 24 hours, of a sequellar radicular neuropathic painy an EVA and affirmed by a DN4 score greater than or equal to 4 |
Countries
France
Contacts
CONTACTErci SALVAT
Outcome results
None listed