Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery

June 30, 2013 updated by: Fereidoun Mortazavi Najafabadi, MD, Isfahan University of Medical Sciences

Comparison of the Effects of Three Methods of Intrathecal Bupivacaine; Bupivacaine-Fentanyl and Bupivacaine-Fentanyl-Magnesium Sulfate on Sensory-Motor Blocks and Postoperative Pain in Patients Undergoing Lumbar Disk Herniation Surgery

The purpose of this study is to Compare three methods of intrathecal bupivacaine; bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and postoperative pain in patients undergoing lumbar disk herniation surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks in patients undergoing lumbar disk herniation surgery
  • Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative pain in patients undergoing lumbar disk herniation surgery
  • Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative side effects in patients undergoing lumbar disk herniation surgery

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

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

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidate for lumbar disk herniation surgery
  • No contraindication to the spinal anesthesia
  • No history of allergy to opioids and magnesium sulfate
  • No peripheral or central neuropathies
  • No previous history of surgery on same disk level

Exclusion Criteria:

  • Patients with intraoperative tearing of dural suc
  • Occuring of inadvertent intraoperative complications such as bleeding

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Magnesium
Patients in group C received a premixed solution of 15 mg hyperbaric bupivacaine 0.5% (3 ml) and 25 µg fentanyl (0.5cc) and 50 mg of magnesium sulfate 50% (0.1 ml) (Pasteur Institute Co, Tehran, Iran) for spinal anesthesia
Drug: Fentanyl
Other Names:
  • Sublimaze
Drug: Bupivacaine
Other Names:
  • Marcaine
Drug: Magnesium Sulfate
Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.
Other Names:
  • Magnesium sulfate 50%
Procedure: Spinal Anesthesia
Lumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally.
ACTIVE_COMPARATOR: Fentanyl
Patients in Fentanyl group received a premixed solution of of 15 mg hyperbaric bupivacaine 0.5% (3 ml) and 25 µg fentanyl (0.5cc),plus 0.1 cc preservative free 0.9% normal saline for spinal anesthesia
Drug: Fentanyl
Other Names:
  • Sublimaze
Drug: Bupivacaine
Other Names:
  • Marcaine
Procedure: Spinal Anesthesia
Lumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally.
ACTIVE_COMPARATOR: Bupivacaine
Patients in Bupivacaine group(control) received a premixed solution of 15 mg of hyperbaric bupivacaine 0.5% (3 ml), plus 0.6 cc preservative free 0.9% normal saline for spinal anesthesia
Drug: Bupivacaine
Other Names:
  • Marcaine
Procedure: Spinal Anesthesia
Lumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The onset of sensory block
Time Frame: From intrathecal injection until the onset of sensory block assessed up to 15 minutes
Comparing the onset of sensory blocks to T10 (10th thoracic dermatome) assessed by pinprick test.
From intrathecal injection until the onset of sensory block assessed up to 15 minutes
The complete motor block
Time Frame: From intrathecal injection until the onset of complete motor block assessed up to 15 minutes
Time to complete motor block after intrathecal injection as assess using a modified Bromage scale
From intrathecal injection until the onset of complete motor block assessed up to 15 minutes
The sensory block regression
Time Frame: From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours
The sensory block regression to (T10) dermatome
From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours
The full motor recovery
Time Frame: From intrathecal injection until the full motor recovery assessed up to 6 hours
Full motor recovery was defined as zero on the Bromage scale.
From intrathecal injection until the full motor recovery assessed up to 6 hours
The Pain Score
Time Frame: The first 24 hours after spinal anesthesia
Using VAS (Visual Analogue Score) system
The first 24 hours after spinal anesthesia
Time to first analgesic requirement
Time Frame: During first 24 hours after spinal anesthesia
Time to first analgesic requirement was measured from the time of spinal injection to the first time at which the patient complained of pain in the postoperative period
During first 24 hours after spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Blood Pressure
Time Frame: First hour after spinal anesthesia
To compare blood pressure alteration and hypotension between three groups
First hour after spinal anesthesia
Heart Rate
Time Frame: First hour after spinal anesthesia
To compare heart rate variation and bradycardia between three groups
First hour after spinal anesthesia

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Chair: Mohammad Ali Attari, MD, Isfahan University of Medical Sciences

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

November 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (ESTIMATE)

April 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2013

Last Update Submitted That Met QC Criteria

June 30, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 392022

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.

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