Can Vitamin C prevent Complex Regional Pain Syndrome in adults undergoing surgery to the foot and ankle? A double-blinded randomised, multi-centre, controlled feasibility study.

Frankston Hospital0 个研究点目标入组 100 人开始时间: 2021年6月28日最近更新: 2021年7月5日

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•Patients need to be aged 18 and over to participate in the trial. This is because most fractures in the lower limb in children are treated non-operatively. In addition, most sites have limited numbers of younger patients who have surgery for foot or ankle problems, recruitment of people under the age of 18 is unfeasible.
•Patients need to be able to provide informed consent for the trial via a signed and dated consent form. Patients who are unable to provide informed consent because of (for example) cognitive impairment will be excluded.
•Patients who present to Peninsula Health, Frankston Private Hospital, Holmesglen Private Hospital, Beleura Private Hospital or Cabrini Brighton Private Hospital for surgery of the foot and ankle, either elective or emergency, will be eligible to participate.

•Current or recent (ie less than three months prior to randomization) use of vitamin C, either as an isolated substance or as part of a multi-vitamin tablet. This is because the vitamin C dosing will not be standardized if patients are also taking the vitamin, and there is potential for overdosing. Vitamin C has a half-life of 10-20 days and therefore a long exclusion period is required.
•Patients who are pregnant or breastfeeding will be excluded due to the unknown safety risks in this patient population.
•Patients who are unable to commence taking the placebo/vitamin C medication within 72 hours after their surgery will be excluded from the trial
•Patients unable or unwilling to take oral medications.
•Patients who are vegan (as the placebo acidophilus is dairy based)

发起方

Frankston Hospital