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 (NeuroPRF)
Primary Purpose
Neuropathic Pain, Chronic Postsurgical Pain
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain, Chronic postsurgical pain prevention, Intraoperative platelet rich fibrin, Disc herniation surgery
Eligibility Criteria
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.
Sites / Locations
- Les Hôpitaux UniversitairesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Surgery for disc herniation and intraoperative periradicular administration of PRF
Surgery for disc herniation alone (i.e. reference treatment).
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05196503
First Posted
August 26, 2021
Last Updated
April 14, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT05196503
Brief Title
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
Acronym
NeuroPRF
Official Title
Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Chronic Postsurgical Pain
Keywords
Neuropathic pain, Chronic postsurgical pain prevention, Intraoperative platelet rich fibrin, Disc herniation surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Surgery for disc herniation and intraoperative periradicular administration of PRF
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Surgery for disc herniation alone (i.e. reference treatment).
Intervention Type
Biological
Intervention Name(s)
Treatment
Intervention Description
Experimental product: product derived from autologous blood, obtained after centrifugation.
Treatment modalities: intraoperative periradicular administration of autologous PRF.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erci SALVAT
Phone
+33 3 88 12 85 02
Email
eric.salvat@chru-strasbourg.fr
Facility Information:
Facility Name
Les Hôpitaux Universitaires
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SALVAT
Phone
+33 3 88 12 85 02
Email
eric.salvat@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Daniel TIMBOLSCHI IONUT
First Name & Middle Initial & Last Name & Degree
Lauriane JOGANAH
First Name & Middle Initial & Last Name & Degree
André MULLER
First Name & Middle Initial & Last Name & Degree
Yohann BOHREN
First Name & Middle Initial & Last Name & Degree
François PROUST
First Name & Middle Initial & Last Name & Degree
Hugo Andres COCA
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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