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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain; Chronic Postsurgical Pain
• Intervention / Treatment: Biological: Treatment

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Erci SALVAT; Phone Number: +33 3 88 12 85 02; Email: eric.salvat@chru-strasbourg.fr

Study Locations

• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67091
      • Recruiting
      • Les Hôpitaux Universitaires
      • Contact: Eric SALVAT; Phone Number: +33 3 88 12 85 02; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): February 23, 2022
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Neuropathic pain; Chronic postsurgical pain prevention; Intraoperative platelet rich fibrin; Disc herniation surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Pain, Postoperative; Hernia; Neuralgia; Intervertebral Disc Displacement
• Other Study ID Numbers: 8363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No