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

Centre Hospitalier Universitaire, Amiens

Status and phase

Enrolling

Phase 3

Conditions

Complex Regional Pain Syndrome (CRPS) TYPE I

Treatments

Drug: Vitamin C

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02390505

2015-000145-24 (EudraCT Number)

PI2015_843_0001

Details and patient eligibility

About

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.

Full 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)

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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