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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000145-24-FR

Enrollment

1000

Registered

2015-06-22

Start date

2015-09-21

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Algoneurodystrophy CRPS type 1 MedDRA version: 18.0 Level: LLT Classification code 10001665 Term: Algoneurodystrophy System Organ Class: 100000004852

Interventions

Product Name: Acide ascorbique Product Code: Vitamine C Pharmaceutical Form: Capsule INN or Proposed INN: C-Vitamin Other descriptive name: L-ASCORBIC ACID Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: - to compare between the 2 arms the occurrence of CRPS Type 1, one year after surgery - Descriptive analysis (overall and per arm) of the population affected by CRPS Type 1: age, sex, history, type of surgery. - Evaluation of tolerance and attendance taking vitamin C in pre and post operative period.;Primary end point(s): Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery;Timepoint(s) of evaluation of this end point: 6 months after surgery	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: - to compare between the 2 arms the occurrence of CRPS Type 1, one year after surgery - Descriptive analysis (overall and per arm) of the population affected by CRPS Type 1: age, sex, history, type of surgery. - Evaluation of tolerance and attendance taking vitamin C in pre and post operative period.;Primary end point(s): Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery;Timepoint(s) of evaluation of this end point: 6 months after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): - Epidemiological description of CRPS affected population - Appearance of a complex regional pain syndrome (CRPS) 12 months after surgery - C Vitamin tolerance and protocol compliance ;Timepoint(s) of evaluation of this end point: 6 and 12 months after surgery	—

Countries

France

Contacts

Public ContactDRCI

CHU Amiens Picardie

fin.loic@chu-amiens.fr33322668060

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026