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

Recruiting
18 years of age
Both
Phase 3

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Overview

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)

Eligibility

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

Study details

Complex Regional Pain Syndrome (CRPS) TYPE I

NCT02390505

Centre Hospitalier Universitaire, Amiens

26 January 2024

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