Complex Regional Pain Syndrome (CRPS) TYPE I
Conditions
Keywords
vitamin C, CRPS, Upper limb surgery
Brief summary
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
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
DRUGVitamin C
DRUGPlacebo
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery | 6 months after surgery | Comparison of the occurrence of participants with CRPS type 1, between the two arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appearance of a complex regional pain syndrome 12 months after surgery | 12 months after surgery | Comparison of the occurrence of participants with CRPS type 1, between the two arms |
| Tolerance | 6 months after surgery | Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration |
| Observance to treatment | 6 months after surgery | The observance to the treatment is estimated based on an adherence form completed by the patient |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREmmanuel DAVID, MD
CHU Amiens
Outcome results
None listed