Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343548
• Other study ID #: 1019-211194
• Status: Completed
• Phase: N/A
• First received: November 12, 2017
• Last updated: April 3, 2018
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: National Research Institute of Tuberculosis and Lung Disease, Iran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• magnesium sulfate
2cc of magnesium sulfate ( 50%) will be administered epidurally
• normal saline
2cc of normal saline will be administered epidurally

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shadi Baniasadi	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Research Institute of Tuberculosis and Lung Disease, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of post-thoracotomy pain	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