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

Neuropathic Pain Clinical Trial

— NeuroPRF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196503
• Other study ID #: 8363
• Status: Recruiting
• Phase: Phase 3
• Start date: February 23, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: Erci SALVAT
• Phone: +33 3 88 12 85 02
• Email: eric.salvat[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Chronic Postsurgical Pain
• Hernia
• Intervertebral Disc Displacement
• Neuralgia
• Neuropathic Pain
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires	Strasbourg	Bas-Rhin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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