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

NCT ID: NCT02455726

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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* 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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Magnesium oxide

Intervention Type DIETARY_SUPPLEMENT

Oral magnesium oxide 300 mg twice a day

Oxycodone

Intervention Type DRUG

Oxycodone hydrochloride 5 mg at 8 am

Pregabalin

Intervention Type DRUG

Pregabalin 25 mg at 8 pm

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).

Group Type PLACEBO_COMPARATOR

Fructose

Intervention Type DIETARY_SUPPLEMENT

Oral fructose 10 g twice a day

Oxycodone

Intervention Type DRUG

Oxycodone hydrochloride 5 mg at 8 am

Pregabalin

Intervention Type DRUG

Pregabalin 25 mg at 8 pm

Interventions

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Magnesium oxide

Oral magnesium oxide 300 mg twice a day

Intervention Type DIETARY_SUPPLEMENT

Fructose

Oral fructose 10 g twice a day

Intervention Type DIETARY_SUPPLEMENT

Oxycodone

Oxycodone hydrochloride 5 mg at 8 am

Intervention Type DRUG

Pregabalin

Pregabalin 25 mg at 8 pm

Intervention Type DRUG

Other Intervention Names

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Oxycontin, Mundipharma Pharmaceutic Lyrica, Pfizer Italia

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Monica Aida Venturini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monica A Venturini, Doctor

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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Monica A Venturini, Doctor

Role: CONTACT

Nicola Latronico, Professor

Role: CONTACT

References

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Other Identifiers

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1601 gluta-aos

Identifier Type: -

Identifier Source: org_study_id

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