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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia |
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* Note: There are 47 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The oxycodone dosage needed to achieve satisfactory analgesia | Patient's satisfactory analgesia is defined as NRS =4 | 14 days | No |
Secondary | Level of pain relief | The level of pain relief is measured using Pain Relief Scale | 2 days | No |
Secondary | Time to satisfactory analgesia | The time needed to achieve satisfactory analgesia (NRS=4) | from 2 to 14 days | No |
Secondary | Time to 50% reduction of pain | The time needed to achieve a reduction of pain of 50% using Pain Relief Scale(PRS = 50%) | from 2 to 14 days | No |
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