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Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery

Who is this study for? Patients with Pain
What treatments are being studied? Surgery for Disc Herniation and Intraoperative Periradicular Administration of PRF
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Les Hôpitaux Universitaires
RECRUITING
Strasbourg
Contact Information
Primary
Erci SALVAT
eric.salvat@chru-strasbourg.fr
+33 3 88 12 85 02
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2028-01
Participants
Target number of participants: 60
Treatments
Active_comparator: Experimental group
Surgery for disc herniation and intraoperative periradicular administration of PRF
Active_comparator: Control group
Surgery for disc herniation alone (i.e. reference treatment).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov