Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Spedali Civili di Brescia; Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Treatments: Magnesium Oxide; Oxycodone; Pregabalin

Criteria

Inclusion Criteria:

• adult patients (18 years or above)

• PAOD at stages III and IV according to the Lèriche-Fontaine classification

• no treatment with opioids at the time of recruitment

Exclusion Criteria:

• renal failure (serum creatinine ≥ 2.0 mg/dl);

• congestive heart failure (New York Heart Association, NYHA > 3);

• treatment with digoxin and/or calcium channel blockers;

• pre-existing neuromuscular diseases;

• chronic diarrhea;

• acute limb ischemia successfully treated with interventional angiography, Fogarty embolectomy and/or surgical revascularization.