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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 (NeuroPRF)

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ClinicalTrials.gov Identifier: NCT05196503
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : March 11, 2022
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Chronic Postsurgical Pain Biological: Treatment Phase 3

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
Actual Study Start Date : February 23, 2022
Actual Primary Completion Date : February 23, 2022
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Experimental group
Surgery for disc herniation and intraoperative periradicular administration of PRF
Biological: Treatment

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

Treatment modalities: intraoperative periradicular administration of autologous PRF.

Active Comparator: Control group
Surgery for disc herniation alone (i.e. reference treatment).
Biological: Treatment

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

Treatment modalities: intraoperative periradicular administration of autologous PRF.

Primary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196503

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Contact: Erci SALVAT +33 3 88 12 85 02 eric.salvat@chru-strasbourg.fr

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Les Hôpitaux Universitaires Recruiting
Strasbourg, Bas-Rhin, France, 67091
Contact: Eric SALVAT    +33 3 88 12 85 02    eric.salvat@chru-strasbourg.fr   
Sub-Investigator: Daniel TIMBOLSCHI IONUT         
Sub-Investigator: Lauriane JOGANAH         
Sub-Investigator: André MULLER         
Sub-Investigator: Yohann BOHREN         
Sub-Investigator: François PROUST         
Sub-Investigator: Hugo Andres COCA         
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT05196503    
Other Study ID Numbers: 8363
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Neuropathic pain
Chronic postsurgical pain prevention
Intraoperative platelet rich fibrin
Disc herniation surgery
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Pain, Postoperative
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes