NeuroPRF: 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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05196503

Collaborator

(none)

Enrollment

Location

Arms

34.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 23, 2022

Actual Primary Completion Date :

Feb 23, 2022

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.