Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02455726
Status:
UNKNOWN
Last Update Posted:
2015-05-28
First Post:
2015-04-23
Brief Title:
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease The MAG-PAPER Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients perceived average and maximum pain using the Numerical Rating Scale NRS 0no pain to 10worst 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 patients 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
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 patients perceived average and maximum pain using the Numerical Rating Scale NRS 0no pain to 10worst 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None