Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 995
- 试验地点
- 6
- 主要终点
- Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
研究概览
简要总结
Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb.
详细描述
The preventive role of vitamin C on the development of CRPS type 1 was already demonstrated in traumatology and foot surgery.
The management of CRPS type 1 is long and expensive. A preventive care seems beneficial. Some studies already performed suggest a similar role in scheduled surgery of the upper limb, major provider of CRPS type 1.The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery. It is a prospective, randomized, double-blind, with placebo use, in two parallel group, multicenter and national. Patients are followed by their surgeon, under the terms of monitoring their disease. Two visits are required: one at 6 months and at 12 months. The patients will be reviewed at least in the two consultations looking for CRPS type 1 according to the criteria of the International Association for the Study of Pain (IASP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •patients over 18 yo
- •patients undergoing major surgery of the upper limb
- •patients able to give their consent to follow the protocol of treatment and monitoring.
排除标准
- •children,
- •patients under guardianship,
- •pregnant or lactating women,
- •patients with hemochromatosis,
- •allergy or known hypersensitivity to one of the molecules of treatment,
- •patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2,
- •patients unable due to personal or professional mobility, to conduct post-operative follow up,
- •patients undergoing surgery with nerve suture with nerve graft, emergency surgery,
- •patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
- •patients with chronic kidney disease
研究组 & 干预措施
Placebo
Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
干预措施: Placebo (Drug)
Vitamin C
Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
干预措施: Vitamin C (Drug)
结局指标
主要结局
Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
时间窗: 6 months after surgery
Comparison of the occurrence of participants with CRPS type 1, between the two arms
次要结局
- Tolerance(6 months after surgery)
- Appearance of a complex regional pain syndrome 12 months after surgery(12 months after surgery)
- Observance to treatment(6 months after surgery)