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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT02390505

Collaborator

(none)

1,000

Enrollment

Locations

Arms

94.5

Anticipated Duration (Months)

333.3

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome (CRPS) TYPE I	Drug: Vitamin C Drug: Placebo	Phase 3

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 18, 2016

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Vitamin C

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

Drug: Vitamin C

Placebo Comparator: Placebo

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

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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