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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Neuropathic Pain Chronic Postsurgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental group

Surgery for disc herniation and intraoperative periradicular administration of PRF

Group Type ACTIVE_COMPARATOR

Treatment

Intervention Type BIOLOGICAL

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

Treatment modalities: intraoperative periradicular administration of autologous PRF.

Control group

Surgery for disc herniation alone (i.e. reference treatment).

Group Type ACTIVE_COMPARATOR

Treatment

Intervention Type BIOLOGICAL

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

Treatment modalities: intraoperative periradicular administration of autologous PRF.

Interventions

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Treatment

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

Treatment modalities: intraoperative periradicular administration of autologous PRF.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No