Status:
UNKNOWN
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
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Neuropathic Pain
Chronic Postsurgical Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, r...
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 randomiz...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05196503
Start Date
February 23 2022
End Date
January 1 2025
Last Update
April 18 2023
Active Locations (1)
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1
Les Hôpitaux Universitaires
Strasbourg, Bas-Rhin, France, 67091