Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

NCT03343548 | Completed DMC

• 1 other identifier: 1019-211194
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

magnesium group (Mg)

Drug: magnesium sulfate

Group II

PLACEBO COMPARATOR

control group (C)

Drug: normal saline

Interventions

magnesium sulfate DRUG

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

Group I

normal saline DRUG

2cc of normal saline will be administered epidurally

Group II

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Institute of Tuberculosis and Lung Disease, Iran: lead

Study Sites (1)

Shadi Baniasadi

Tehran, 19569-44413, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 17, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)