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

Primary Purpose

Lumbar Spine Disc Herniation

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Spinal Anesthesia
Bupivacaine
Fentanyl
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lumbar Spine Disc Herniation focused on measuring Spinal Anesthesia, Bupivacaine, Fentanyl, Magnesium sulfate, Postoperative Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alzahra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Magnesium

Fentanyl

Bupivacaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The onset of sensory block
Comparing the onset of sensory blocks to T10 (10th thoracic dermatome) assessed by pinprick test.
The complete motor block
Time to complete motor block after intrathecal injection as assess using a modified Bromage scale
The sensory block regression
The sensory block regression to (T10) dermatome
The full motor recovery
Full motor recovery was defined as zero on the Bromage scale.
The Pain Score
Using VAS (Visual Analogue Score) system
Time to first analgesic requirement
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

Secondary Outcome Measures

Mean Arterial Blood Pressure
To compare blood pressure alteration and hypotension between three groups
Heart Rate
To compare heart rate variation and bradycardia between three groups

Full Information

First Posted
April 24, 2013
Last Updated
June 30, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01843296
Brief Title
Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disc Herniation
Keywords
Spinal Anesthesia, Bupivacaine, Fentanyl, Magnesium sulfate, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Magnesium sulfate 50%
Intervention Description
Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Sublimaze
Primary Outcome Measure Information:
Title
The onset of sensory block
Description
Comparing the onset of sensory blocks to T10 (10th thoracic dermatome) assessed by pinprick test.
Time Frame
From intrathecal injection until the onset of sensory block assessed up to 15 minutes
Title
The complete motor block
Description
Time to complete motor block after intrathecal injection as assess using a modified Bromage scale
Time Frame
From intrathecal injection until the onset of complete motor block assessed up to 15 minutes
Title
The sensory block regression
Description
The sensory block regression to (T10) dermatome
Time Frame
From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours
Title
The full motor recovery
Description
Full motor recovery was defined as zero on the Bromage scale.
Time Frame
From intrathecal injection until the full motor recovery assessed up to 6 hours
Title
The Pain Score
Description
Using VAS (Visual Analogue Score) system
Time Frame
The first 24 hours after spinal anesthesia
Title
Time to first analgesic requirement
Description
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
Time Frame
During first 24 hours after spinal anesthesia
Secondary Outcome Measure Information:
Title
Mean Arterial Blood Pressure
Description
To compare blood pressure alteration and hypotension between three groups
Time Frame
First hour after spinal anesthesia
Title
Heart Rate
Description
To compare heart rate variation and bradycardia between three groups
Time Frame
First hour after spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Attari, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Alzahra
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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