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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-18

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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)

Conditions

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Complex Regional Pain Syndrome (CRPS) TYPE I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin C

Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DRUG

Placebo

Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vitamin C

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No