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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    1000
  • sponsor
    Centre Hospitalier Universitaire, Amiens
Updated on 23 February 2022

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.

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)

Details
Condition Complex Regional Pain Syndrome (CRPS) TYPE I
Treatment Placebo, Vitamin C
Clinical Study IdentifierNCT02390505
SponsorCentre Hospitalier Universitaire, Amiens
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

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
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