Trials / Unknown
UnknownNCT05196503
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
Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University Hospital, Strasbourg, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Treatment | Experimental product: product derived from autologous blood, obtained after centrifugation. Treatment modalities: intraoperative periradicular administration of autologous PRF. |
Timeline
- Start date
- 2022-02-23
- Primary completion
- 2022-02-23
- Completion
- 2025-01-01
- First posted
- 2022-01-19
- Last updated
- 2023-04-18
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05196503. Inclusion in this directory is not an endorsement.