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

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Regional Pain Syndrome (CRPS) TYPE I
• Intervention / Treatment: Drug: Placebo; Drug: Vitamin C

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens
  • Rouen, France, 76031
    • Not yet recruiting
    • CHU Rouen
  • Saint-Quentin, France, 02321
    • Not yet recruiting
    • CH Saint-Quentin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2016
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (ESTIMATE): March 17, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: CRPS; vitamin C; Upper limb surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: PI2015_843_0001; 2015-000145-24 (EUDRACT_NUMBER)