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

Complex Regional Pain Syndrome (CRPS) TYPE I Clinical Trial

— SDRC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02390505
• Other study ID #: PI2015_843_0001
• Secondary ID: 2015-000145-24
• Status: Recruiting
• Phase: Phase 3
• Start date: July 18, 2016
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome (CRPS) TYPE I
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Vitamin C

• Placebo

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Rouen	Rouen
France	CH Saint-Quentin	Saint-Quentin

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Tolerance	Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration	6 months after surgery
Secondary	Observance to treatment	The observance to the treatment is estimated based on an adherence form completed by the patient	6 months after surgery