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Trial record 2 of 130 for:    Complex Regional Pain Syndrome

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

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ClinicalTrials.gov Identifier: NCT02390505
Recruitment Status : Unknown
Verified August 2016 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Recruiting
First Posted : March 17, 2015
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome (CRPS) TYPE I Drug: Vitamin C Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Tolerance [ Time Frame: 6 months after surgery ]
    Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390505


Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: David Emmanuel, MD    +33322087167    david.emmanuel@chu-amiens.fr   
Principal Investigator: Emmanuel DAVID, MD         
CHU Rouen Not yet recruiting
Rouen, France, 76031
Contact: Isabelle AUQUIT-AUCKBUR, MD-PhD       Isabelle.Auquit@chu-rouen.fr   
Principal Investigator: Isabelle AUQUIT-AUCKBUR, MD-PhD         
CH Saint-Quentin Not yet recruiting
Saint-Quentin, France, 02321
Contact: Mirdad MOUGHABGHAB, MD       sosmain@ch-stquentin.fr   
Principal Investigator: Mirdad MOUGHABGHAB, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Emmanuel DAVID, MD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02390505     History of Changes
Other Study ID Numbers: PI2015_843_0001
2015-000145-24 ( EudraCT Number )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
vitamin C
CRPS
Upper limb surgery

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents