Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Time Frame: 6 months
Average intensity, over 24 hours, of a sequellar radicular neuropathic painy an EVA and affirmed by a DN4 score greater than or equal to 4