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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium | Active Comparator | 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 |
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| Fentanyl | Active Comparator | 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 |
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| Bupivacaine | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Ali Attari, MD | Isfahan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzahra | Isfahan | Isfahan | Iran |
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| Spinal Anesthesia | Procedure | 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. |
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| Bupivacaine | Drug |
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| Fentanyl | Drug |
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| First hour after spinal anesthesia |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000775 | Anesthesia, Spinal |
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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