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

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ClinicalTrials.gov Identifier: NCT02455726
Recruitment Status : Unknown
Verified May 2015 by Monica Aida Venturini, Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was:  Not yet recruiting
First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Monica Aida Venturini, Azienda Ospedaliera Spedali Civili di Brescia

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Dietary Supplement: Magnesium oxide Dietary Supplement: Fructose Drug: Oxycodone Drug: Pregabalin Not Applicable

Detailed Description:
  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease: The MAG-PAPER Randomized Clinical Trial
Study Start Date : September 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mg-group

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
Oral magnesium oxide 300 mg twice a day

Drug: Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
Other Name: Oxycontin, Mundipharma Pharmaceutic

Drug: Pregabalin
Pregabalin 25 mg at 8 pm
Other Name: Lyrica, Pfizer Italia

Placebo Comparator: C-group

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
Oral fructose 10 g twice a day

Drug: Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
Other Name: Oxycontin, Mundipharma Pharmaceutic

Drug: Pregabalin
Pregabalin 25 mg at 8 pm
Other Name: Lyrica, Pfizer Italia




Primary Outcome Measures :
  1. The oxycodone dosage needed to achieve satisfactory analgesia [ Time Frame: 14 days ]
    Patient's satisfactory analgesia is defined as NRS ≤4


Secondary Outcome Measures :
  1. Level of pain relief [ Time Frame: 2 days ]
    The level of pain relief is measured using Pain Relief Scale

  2. Time to satisfactory analgesia [ Time Frame: from 2 to 14 days ]
    The time needed to achieve satisfactory analgesia (NRS≤4)

  3. Time to 50% reduction of pain [ Time Frame: from 2 to 14 days ]
    The time needed to achieve a reduction of pain of 50% using Pain Relief Scale(PRS = 50%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455726


Contacts
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Contact: Monica A Venturini, Doctor monica.venturini@spedalicivili.brescia.it
Contact: Nicola Latronico, Professor nicola.latronico@unibs.it

Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
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Principal Investigator: Monica A Venturini, Doctor

Publications:
Recio-Pinto E, Castillo C. Peripheral N-methyl-D-aspartate receptors as possible targets for chronic pain treatment. Techniques in Reg Anesth & Pain Manag 2010;14:48-58

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Monica Aida Venturini, MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT02455726     History of Changes
Other Study ID Numbers: 1601 gluta-aos
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Monica Aida Venturini, Azienda Ospedaliera Spedali Civili di Brescia:
Peripheral Arterial Disease
Magnesium Oxide
Pain

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Pregabalin
Oxycodone
Magnesium Oxide
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Opioid
Narcotics
Antacids
Gastrointestinal Agents