Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group
Surgery for disc herniation and intraoperative periradicular administration of PRF
干预措施: Treatment (Biological)
Control group
Surgery for disc herniation alone (i.e. reference treatment).
干预措施: Treatment (Biological)
结局指标
主要结局
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.
时间窗: 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
次要结局
未报告次要终点