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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2023

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)

Interventions

  • Drug: Vitamin C
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Vitamin C
    • Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
  • Placebo Comparator: Placebo
    • Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery

Clinical Trial Outcome Measures

Primary Measures

  • Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
    • Time Frame: 6 months after surgery
    • Comparison of the occurrence of participants with CRPS type 1, between the two arms

Secondary Measures

  • Appearance of a complex regional pain syndrome 12 months after surgery
    • Time Frame: 12 months after surgery
    • Comparison of the occurrence of participants with CRPS type 1, between the two arms
  • Tolerance
    • Time Frame: 6 months after surgery
    • Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration
  • Observance to treatment
    • Time Frame: 6 months after surgery
    • The observance to the treatment is estimated based on an adherence form completed by the patient

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire, Amiens
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emmanuel DAVID, MD, Principal Investigator, CHU Amiens

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