Clinical trial NCT02390505: Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
Official title: Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Complex Regional Pain Syndrome (CRPS) TYPE I
Keywords: vitamin C
CRPS
Upper limb surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Appearance of a complex regional pain syndrome 12 months after surgery
timeFrame: 12 months after surgery
measure: Tolerance
timeFrame: 6 months after surgery
measure: Observance to treatment
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Quentin
country: France
facility: CH Saint-Quentin
Study officials:
affiliation: CHU Amiens
name: Emmanuel DAVID, MD
role: PRINCIPAL_INVESTIGATOR
References: