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

Study Overview
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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.

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)

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

Conditions
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Complex Regional Pain Syndrome (CRPS) TYPE I

Intervention / Treatment
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* Drug: Vitamin C
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C<br>Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery | Drug: Vitamin C<br> <br> |
| Placebo Comparator: Placebo<br>Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery | Comparison of the occurrence of participants with CRPS type 1, between the two arms | 6 months after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin C, CRPS, Upper limb surgery