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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000145-24 | EudraCT Number |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Experimental | Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery |
|
| Placebo | Placebo Comparator | Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel DAVID, MD | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France | |||
| CHU Rouen |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 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 |
| Rouen |
| 76031 |
| France |
| CH Saint-Quentin | Saint-Quentin | 02321 | France |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |