Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

April 3, 2018 updated by: Shadi Baniasadi, National Research Institute of Tuberculosis and Lung Disease, Iran

The Effect of Adjuvant Epidural Magnesium Sulfate to Bupivacaine and Morphine on Post-thoracotomy Pain Control: A Randomized Double Blind Clinical Trial Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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.

Study Locations

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

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
magnesium group (Mg)
Drug: magnesium sulfate
2cc of magnesium sulfate ( 50%) will be administered epidurally
Placebo Comparator: Group II
control group (C)
Drug: normal saline
2cc of normal saline will be administered epidurally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of post-thoracotomy pain
Time Frame: 24 hours after thoracotomy
VAS (visual analog scale: 0-10 cm (0 cm = no pain and 10 cm = the worst pain)) score will be measured
24 hours after thoracotomy

Collaborators and Investigators

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

Sponsor

National Research Institute of Tuberculosis and Lung Disease, Iran

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 (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

November 12, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1019-211194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Pain

Clinical Trials on magnesium sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe