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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

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

Recruiting
18 years and older
All
Phase 3

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Overview

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.

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).

Eligibility

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.

Study details
    Neuropathic Pain
    Chronic Postsurgical Pain

NCT05196503

University Hospital, Strasbourg, France

27 June 2026

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