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

May 25, 2015 updated by: Monica Aida Venturini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Oxycontin, Mundipharma Pharmaceutic
Drug: Pregabalin
Pregabalin 25 mg at 8 pm
Other Names:
  • 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).
Drug: Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
Other Names:
  • Oxycontin, Mundipharma Pharmaceutic
Drug: Pregabalin
Pregabalin 25 mg at 8 pm
Other Names:
  • Lyrica, Pfizer Italia
Dietary supplement: Fructose
Oral fructose 10 g twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The oxycodone dosage needed to achieve satisfactory analgesia
Time Frame: 14 days
Patient's satisfactory analgesia is defined as NRS ≤4
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of pain relief
Time Frame: 2 days
The level of pain relief is measured using Pain Relief Scale
2 days
Time to satisfactory analgesia
Time Frame: from 2 to 14 days
The time needed to achieve satisfactory analgesia (NRS≤4)
from 2 to 14 days
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%)
from 2 to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Monica A Venturini, Doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

May 25, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 25, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1601 gluta-aos

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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