Peripheral Arterial Disease Clinical Trial
Official title:
Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease: The MAG-PAPER Randomized Clinical Trial
Magnesium exerts analgesic effects in several animal pain models and in patients affected by
acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that
magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).
We describe the protocol of a single-center randomized double-blind clinical trial aimed at
assessing the efficacy of oral magnesium supplementation in controlling severe pain in
patients with advanced PAOD.
- Adult patients admitted to our Acute Pain Service for intractable pain will be eligible
if they are affected by PAOD at stages III and IV of Lèriche-Fontaine classification,
and are opioid-naïve.
- Patients enrolled will be randomized to the control group, treated with standard
therapy, consisting of an oral administration of oxycodone 5 mg and pregabalin 25 mg
per day plus placebo (fructose 10 g) twice a day for two weeks, or to the experimental
group, treated with magnesium oxide 300 mg twice a day.
- Randomization will be computer-generated, with allocation concealment obtained using
opaque, sequentially numbered and sealed envelopes. Trials participants, care
providers, data collectors, outcome assessors and data analysts will be blinded to
treatment allocation.
- Patients will be evaluated on the day of hospital admission (day 0) and on days 2, 4,
6, 8, 12, and 14 with the following information being collected: daily oxycodone dose
received; patient's perceived average and maximum pain using the Numerical Rating Scale
(NRS: 0=no pain to 10=worst possible pain); pain relief using Pain Relief Scale (PRS:
0% no pain relief to 100% complete pain relief); characteristics of the pain, using the
Neuropathic Pain Scale (NPS: 10 items); impact of pain on the patient's daily
activities, using the Brief Pain Inventory (BPI; 9 items).
- A sample size calculation performed for the primary outcome showed that 150 patients
(75 per group) are needed to achieve 90% power to detect a minimum reduction of 30% in
oxycodone dosage in the experimental group, after allowing for a drop-out rate of
around 20%.
- Ethical approval of the study protocol has been obtained from Comitato Etico
Provinciale di Brescia, Brescia, Italy.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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