Clinical trial NCT05196503: 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
Official title: Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neuropathic Pain
Chronic Postsurgical Pain
Keywords: Neuropathic pain
Chronic postsurgical pain prevention
Intraoperative platelet rich fibrin
Disc herniation surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires
state: Bas-Rhin
Study officials:
References: