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Completed

NCT Number: NCT03343548

Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

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.

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Key information

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shadi Baniasadi

Tehran, 19569-44413, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

normal saline

Drug

2cc of normal saline will be administered epidurally

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Research Institute of Tuberculosis and Lung Disease, Iran

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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