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

Phase 3

Recruiting

• Conditions: Neuropathic Pain; Chronic Postsurgical Pain
• Interventions: Biological: Treatment

• Registration Number: NCT05196503
• Lead Sponsor: University Hospital, Strasbourg, France

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).

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-19
• Study Start: 2022-02-23
• Primary Completion: 2022-02-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Treatment	Surgery for disc herniation alone (i.e. reference treatment).
Experimental group	Treatment	Surgery for disc herniation and intraoperative periradicular administration of PRF

Primary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

Les Hôpitaux Universitaires; 🇫🇷 Strasbourg, Bas-Rhin, France