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

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium oxide
Fructose
Oxycodone
Pregabalin
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Magnesium Oxide, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mg-group

    C-group

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    The oxycodone dosage needed to achieve satisfactory analgesia
    Patient's satisfactory analgesia is defined as NRS ≤4

    Secondary Outcome Measures

    Level of pain relief
    The level of pain relief is measured using Pain Relief Scale
    Time to satisfactory analgesia
    The time needed to achieve satisfactory analgesia (NRS≤4)
    Time to 50% reduction of pain
    The time needed to achieve a reduction of pain of 50% using Pain Relief Scale(PRS = 50%)

    Full Information

    First Posted
    April 23, 2015
    Last Updated
    May 25, 2015
    Sponsor
    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02455726
    Brief Title
    Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
    Official Title
    Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease: The MAG-PAPER Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease
    Keywords
    Peripheral Arterial Disease, Magnesium Oxide, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mg-group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    C-group
    Arm Type
    Placebo Comparator
    Arm Description
    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).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Magnesium oxide
    Intervention Description
    Oral magnesium oxide 300 mg twice a day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fructose
    Intervention Description
    Oral fructose 10 g twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone
    Other Intervention Name(s)
    Oxycontin, Mundipharma Pharmaceutic
    Intervention Description
    Oxycodone hydrochloride 5 mg at 8 am
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin
    Other Intervention Name(s)
    Lyrica, Pfizer Italia
    Intervention Description
    Pregabalin 25 mg at 8 pm
    Primary Outcome Measure Information:
    Title
    The oxycodone dosage needed to achieve satisfactory analgesia
    Description
    Patient's satisfactory analgesia is defined as NRS ≤4
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Level of pain relief
    Description
    The level of pain relief is measured using Pain Relief Scale
    Time Frame
    2 days
    Title
    Time to satisfactory analgesia
    Description
    The time needed to achieve satisfactory analgesia (NRS≤4)
    Time Frame
    from 2 to 14 days
    Title
    Time to 50% reduction of pain
    Description
    The time needed to achieve a reduction of pain of 50% using Pain Relief Scale(PRS = 50%)
    Time Frame
    from 2 to 14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monica A Venturini, Doctor
    Email
    monica.venturini@spedalicivili.brescia.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicola Latronico, Professor
    Email
    nicola.latronico@unibs.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Monica A Venturini, Doctor
    Official's Role
    Principal Investigator

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

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