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

NCT02455726 | Unknown

• 1 other identifier: 1601 gluta-aos
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Magnesium Oxide; Pain

Outcome Measures

Primary Outcomes (1)

• The oxycodone dosage needed to achieve satisfactory analgesia

  Patient's satisfactory analgesia is defined as NRS ≤4

  14 days

Secondary Outcomes (3)

• Level of pain relief

  2 days

• Time to satisfactory analgesia

  from 2 to 14 days

• Time to 50% reduction of pain

  from 2 to 14 days

Study Arms (2)

Mg-group

EXPERIMENTAL

Standard therapy plus magnesium oxide. * Standard therapy: oxycodone 5 mg and pregabalin 25 mg per day for two weeks. Starting by day 2, the opioid dose will be titrated every 48 hours in order to reach the maximum therapeutic goal and to minimize side effects. * A rescue dose: paracetamol 1g (maximum dose 3 g per day).

Dietary Supplement: Magnesium oxide; Drug: Oxycodone; Drug: Pregabalin

C-group

PLACEBO COMPARATOR

Standard therapy plus fructose. * Standard therapy: oxycodone 5 mg and pregabalin 25 mg per day for two weeks. Starting by day 2, the opioid dose will be titrated every 48 hours in order to reach the maximum therapeutic goal and to minimize side effects. * A rescue dose: paracetamol 1g (maximum dose 3 g per day).

Dietary Supplement: Fructose; Drug: Oxycodone; Drug: Pregabalin

Interventions

Magnesium oxide DIETARY_SUPPLEMENT

Oral magnesium oxide 300 mg twice a day

Mg-group

Fructose DIETARY_SUPPLEMENT

Oral fructose 10 g twice a day

C-group

Oxycodone DRUG

Oxycodone hydrochloride 5 mg at 8 am

Also known as: Oxycontin, Mundipharma Pharmaceutic

C-group; Mg-group

Pregabalin DRUG

Pregabalin 25 mg at 8 pm

Also known as: Lyrica, Pfizer Italia

C-group; Mg-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

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MeSH Terms

Conditions

Peripheral Arterial Disease; Pain

Interventions

Magnesium Oxide; Fructose; Oxycodone; Pregabalin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Monica A Venturini, Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica A Venturini, Doctor

CONTACT

monica.venturini@spedalicivili.brescia.it

Nicola Latronico, Professor

CONTACT

nicola.latronico@unibs.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 28, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 28, 2015

Record last verified: 2015-05