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

Phase 3

Recruiting

• Conditions: Complex Regional Pain Syndrome (CRPS) TYPE I
• Interventions: Drug: Vitamin C; Drug: Placebo

• Registration Number: NCT02390505
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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)

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Study Start: 2016-07-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C	Vitamin C	Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
Placebo	Placebo	Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Tolerance	6 months after surgery	Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration
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
Observance to treatment	6 months after surgery	The observance to the treatment is estimated based on an adherence form completed by the patient

Trial Locations

Locations (3)

CHU Rouen; 🇫🇷 Rouen, France

CH Saint-Quentin; 🇫🇷 Saint-Quentin, France

CHU Amiens; 🇫🇷 Amiens, France