NCT02390505

Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Complex Regional Pain Syndrome (CRPS) TYPE I

Interventions

Type	Name	Description
DRUG	Vitamin C
DRUG	Placebo

Timeline

• Start date: 2016-07-18
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2015-03-17
• Last updated: 2023-02-09

Locations

3 sites across 1 country: France