Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery (SDRC)
Primary Purpose
Complex Regional Pain Syndrome (CRPS) TYPE I
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Complex Regional Pain Syndrome (CRPS) TYPE I focused on measuring vitamin C, CRPS, Upper limb surgery
Eligibility 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
Sites / Locations
- CHU AmiensRecruiting
- CHU Rouen
- CH Saint-Quentin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin C
Placebo
Arm Description
Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Tolerance
Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration
Observance to treatment
The observance to the treatment is estimated based on an adherence form completed by the patient
Full Information
NCT ID
NCT02390505
First Posted
February 16, 2015
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02390505
Brief Title
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
Acronym
SDRC
Official Title
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome (CRPS) TYPE I
Keywords
vitamin C, CRPS, Upper limb surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
Description
Comparison of the occurrence of participants with CRPS type 1, between the two arms
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Appearance of a complex regional pain syndrome 12 months after surgery
Description
Comparison of the occurrence of participants with CRPS type 1, between the two arms
Time Frame
12 months after surgery
Title
Tolerance
Description
Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration
Time Frame
6 months after surgery
Title
Observance to treatment
Description
The observance to the treatment is estimated based on an adherence form completed by the patient
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel DAVID, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Emmanuel, MD
Phone
+33322087167
Email
david.emmanuel@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel DAVID, MD
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle AUQUIT-AUCKBUR, MD-PhD
Email
Isabelle.Auquit@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Isabelle AUQUIT-AUCKBUR, MD-PhD
Facility Name
CH Saint-Quentin
City
Saint-Quentin
ZIP/Postal Code
02321
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirdad MOUGHABGHAB, MD
Email
sosmain@ch-stquentin.fr
First Name & Middle Initial & Last Name & Degree
Mirdad MOUGHABGHAB, MD
12. IPD Sharing Statement
Learn more about this trial
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
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