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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment

    Biological/Vaccine

    Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental groupActive comparator 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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