NCT Number: NCT02390505
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
CHU Amiens, Amiens, France
About this study
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)
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
Time frame: 6 months after surgery
Comparison of the occurrence of participants with CRPS type 1, between the two arms
Secondary outcomes
-
Appearance of a complex regional pain syndrome 12 months after surgery
Time frame: 12 months after surgery
Comparison of the occurrence of participants with CRPS type 1, between the two arms
-
Tolerance
Time frame: 6 months after surgery
Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration
-
Observance to treatment
Time frame: 6 months after surgery
The observance to the treatment is estimated based on an adherence form completed by the patient
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Other
Registry information
Acronym: SDRC
Important dates
- Study start
- 2016
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Mar 17, 2015
- Registry last updated
- Jun 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Empowered Relief for Youth
NCT05998369
Abdominal Pain, Autonomic Nervous System Diseases
Palo Alto, California, United States
View Trial DetailsInterest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
NCT04913051
Autonomic Nervous System Diseases, Chronic Regional Pain Syndrome
Le Mans, France
View Trial DetailsEvaluation of the Relationship Between the Duration of the Evolution of the Complex Regional Pain Syndrome Type 1 (CRPS 1) and Effectiveness of the Continuous Peripheral Nerve Block (CPNB) Associated With an Intensive Rehabilitation Program
NCT04767646
Autonomic Nervous System Diseases, CRPS (Complex Regional Pain Syndrome) Type I
Rennes, Brittany Region, France
View Trial DetailsEffects of Motor Imagery Technique With and Without Virtual Reality on Pain Intensity ,Functional Disability and Quality of Life in Patient With Post Stroke Shoulder Hand Syndrome
NCT07610889
Autonomic Nervous System Diseases, Complex Regional Pain Syndrome (CRPS)
Lahore, Punjab Province, Pakistan
View Trial Details