Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery

Conditions
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Neuropathic Pain, Chronic Postsurgical Pain

Intervention / Treatment
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* Biological: Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>Surgery for disc herniation and intraoperative periradicular administration of PRF | Biological: Treatment<br>* Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.<br>|
| Active Comparator: Control group<br>Surgery for disc herniation alone (i.e. reference treatment). | Biological: Treatment<br>* Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Chronic postsurgical pain prevention, Intraoperative platelet rich fibrin, Disc herniation surgery