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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Lumbar Spine Disc Herniation

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Procedure: Spinal Anesthesia
* Drug: Bupivacaine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium<br>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: Magnesium Sulfate<br>* Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.<br>* Other names: Magnesium sulfate 50%;Procedure: Spinal Anesthesia<br>* 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.<br>Drug: Bupivacaine<br> <br> * Other names: Marcaine;Drug: Fentanyl<br> <br> * Other names: Sublimaze;|
| Active Comparator: Fentanyl<br>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 | Procedure: Spinal Anesthesia<br>* 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.<br>Drug: Bupivacaine<br> <br> * Other names: Marcaine;Drug: Fentanyl<br> <br> * Other names: Sublimaze;|
| Active Comparator: Bupivacaine<br>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 | Procedure: Spinal Anesthesia<br>* 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.<br>Drug: Bupivacaine<br> <br> * Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset of sensory block | 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 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 | 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 | 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 | Using VAS (Visual Analogue Score) system | The first 24 hours after spinal anesthesia | 
| 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 | During first 24 hours after spinal anesthesia | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Anesthesia, Bupivacaine, Fentanyl, Magnesium sulfate, Postoperative Pain