Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

NCT ID: NCT03343548

Last Updated: 2018-04-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

Brief Summary

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Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic epidural analgesia has greatly decreased the pain experience and its consequences. However, new ways of decreasing post-operative opioid drugs consumption is an important issue of research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled in a randomized double blind trial. Patients randomly will be allocated in two groups. Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients at the end of operation. Patients in group I will be received epidural magnesium sulfate (50 mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog scale (VAS) score and the amount of morphine consumption will be measured during 24 hours post-operation.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I

magnesium group (Mg)

Group Type ACTIVE_COMPARATOR

magnesium sulfate

Intervention Type DRUG

2cc of magnesium sulfate ( 50%) will be administered epidurally

Group II

control group (C)

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

2cc of normal saline will be administered epidurally

Interventions

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magnesium sulfate

2cc of magnesium sulfate ( 50%) will be administered epidurally

Intervention Type DRUG

normal saline

2cc of normal saline will be administered epidurally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical statuses I-III
* Undergoing thoracotomy

Exclusion Criteria

* Known hypersensitivity to magnesium sulfate
* Renal failure
* Hepatic dysfunction
* Severe obesity
* Psychotic or neurologic diseases
* Currently taking opioid or calcium channel blocker
* AV block degree II or III
* Refused to participate in trial
Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Institute of Tuberculosis and Lung Disease, Iran

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shadi Baniasadi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shadi Baniasadi

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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1019-211194

Identifier Type: -

Identifier Source: org_study_id

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