Clinical trial

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

Name
8363
Description
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.
Trial arms
Trial start
2022-02-23
Estimated PCD
2022-02-23
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Treatment
Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.
Arms:
Control group, Experimental group
Size
60
Primary endpoint
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

1 drug

2 indications