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

NCT02390505 | Completed Phase 3

• 2 other identifiers: PI2015_843_00012015-000145-24
• Study Type: interventional
• Target: 995
• Locations: 1 country
• Sites: 3

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.

Conditions

Complex Regional Pain Syndrome (CRPS) TYPE I

Keywords

vitamin C; CRPS; Upper limb surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Appearance of a complex regional pain syndrome 12 months after surgery

  12 months after surgery

• Tolerance

  6 months after surgery

• Observance to treatment

  6 months after surgery

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

PLACEBO COMPARATOR

Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery

Drug: Placebo

Interventions

Vitamin C DRUG

Vitamin C

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (3)

CHU Amiens

Amiens, 80054, France

Location

CHU Rouen

Rouen, 76031, France

Location

CH Saint-Quentin

Saint-Quentin, 02321, France

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Emmanuel DAVID, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 17, 2015
• Study Start: July 18, 2016
• Primary Completion: July 7, 2025
• Study Completion: December 8, 2025
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

FR (3)