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NCT Number: NCT05196503

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Les Hôpitaux Universitaires

Strasbourg, Bas-Rhin, 67091, France

Location status: Recruiting

Location contact

André MULLER

SUB_INVESTIGATOR

Daniel TIMBOLSCHI IONUT

SUB_INVESTIGATOR

Eric SALVAT

CONTACT

[email protected]

+33 3 88 12 85 02

François PROUST

SUB_INVESTIGATOR

Hugo Andres COCA

SUB_INVESTIGATOR

Lauriane JOGANAH

SUB_INVESTIGATOR

Yohann BOHREN

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment

Biological

Experimental product: product derived from autologous blood, obtained after centrifugation.

Treatment modalities: intraoperative periradicular administration of autologous PRF.

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.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: NeuroPRF

Important dates

Study start
2022
Primary completion
2022
Study completion
2028
First posted
Jan 19, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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