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
| NCT ID | NCT05196503 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2022-02-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2022-02-23 with a primary completion date of 2022-02-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05196503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05196503 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT05196503 currently recruiting?
Yes, NCT05196503 is actively recruiting participants. Contact the research team at eric.salvat@chru-strasbourg.fr for enrollment information.
Where is the NCT05196503 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT05196503 clinical trial?
NCT05196503 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 60 participants.