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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The sensory block regression
研究概览
简要总结
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.
详细描述
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patients with intraoperative tearing of dural suc
- •Occuring of inadvertent intraoperative complications such as bleeding
研究组 & 干预措施
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
干预措施: Magnesium Sulfate (Drug)
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
干预措施: Spinal Anesthesia (Procedure)
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
干预措施: Bupivacaine (Drug)
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
干预措施: Fentanyl (Drug)
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
干预措施: Spinal Anesthesia (Procedure)
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
干预措施: Bupivacaine (Drug)
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
干预措施: Fentanyl (Drug)
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
干预措施: Spinal Anesthesia (Procedure)
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
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The sensory block regression
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: The first 24 hours after spinal anesthesia
Using VAS (Visual Analogue Score) system
Time to first analgesic requirement
时间窗: 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
次要结局
- Mean Arterial Blood Pressure(First hour after spinal anesthesia)
- Heart Rate(First hour after spinal anesthesia)
研究者
Fereidoun Mortazavi Najafabadi, MD
fellowship of neuroanesthesia
Isfahan University of Medical Sciences