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Completed

NCT Number: NCT02390505

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens, Amiens, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Tolerance

    Time frame: 6 months after surgery

    Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: SDRC

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2015
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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