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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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)


Sponsor: Centre Hospitalier Universitaire, Amiens

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: February 16, 2015
Date Started: July 2016
Date Completion: June 2018
Last Updated: August 3, 2016
Last Verified: August 2016