None listed
Conditions
Brief summary
We propose a randomised, controlled, feasibility study to determine the effectiveness of Vitamin C in the prevention of Complex Regional Pain Syndrome (CRPS) following lower limb surgery. This feasibility study will observe whether the proposed protocol is practical and replicable, and determine whether further study in this area needs to be adapted. We also expect to find a decrease in incidence of CRPS following administration of Vitamin C after surgery.
Interventions
Vitamin C 500mg daily orally for fifty days.
Vitamin C will commence within 72 hours following surgery (to allow for weekend and overnight admissions), and continuing for fifty days after commencement.
Patients will be reviewed two, six, twelve and twenty-six weeks following surgery. They will be asked directly about adherence to the medication as well as any adverse effects.
Sponsors
Frankston Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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.
Exclusion criteria
• 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)
Outcome results
None listed