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
Overview
- Phase
- Phase 4
- Intervention
- Magnesium Sulfate
- Conditions
- Lumbar Spine Disc Herniation
- Sponsor
- Isfahan University of Medical Sciences
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- The sensory block regression
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Fereidoun Mortazavi Najafabadi, MD
fellowship of neuroanesthesia
Isfahan University of Medical Sciences
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
Arms & Interventions
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
Intervention: Magnesium Sulfate
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
Intervention: Spinal Anesthesia
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
Intervention: Bupivacaine
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
Intervention: Fentanyl
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
Intervention: Spinal Anesthesia
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
Intervention: Bupivacaine
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
Intervention: Fentanyl
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
Intervention: Spinal Anesthesia
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
Intervention: Bupivacaine
Outcomes
Primary Outcomes
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
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.
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
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.
The Pain Score
Time Frame: The first 24 hours after spinal anesthesia
Using VAS (Visual Analogue Score) system
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
Secondary Outcomes
- Mean Arterial Blood Pressure(First hour after spinal anesthesia)
- Heart Rate(First hour after spinal anesthesia)