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)

University Hospital, Strasbourg, France

Status and phase: Enrolling; Phase 3

Conditions: Neuropathic Pain; Chronic Postsurgical Pain

Treatments: Biological: Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05196503

8363

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Experimental group

Active Comparator group

Description:

Surgery for disc herniation and intraoperative periradicular administration of PRF

Treatment:

Biological: Treatment

Control group

Active Comparator group

Description:

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

Treatment:

Biological: Treatment