A Comparative study of Hyperbaric Levobupivacaine 0.5 percent with Hyperbaric Levobupivacaine 0.5 percent plus Fentanyl on Sensory and Motor characteristics for Spinal Anaesthesia in Infra Umbilical surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Onset of sensory block, time for maximum sensory blockade, two segment sensory regression, duration of sensory block,onset of motor blockade, maximum motor block, duration of motor block, duration of analgesia.
研究概览
简要总结
Subarachnoid block (SAB) is a technique of regional anesthesia widely used for surgery of lower limbs, pelvic organs,lower abdomen and for cesarean sections because of its simplicity, rapid onset and reliability¹.
Hyperbaric bupivacaine 0.5%, an amide local anesthetic is presently the most common drug used for obstetric anaesthesia2 .Following the reports of cardiovascular toxic effects of bupivacaine by Albrights in 1979, relative pharmacological behaviors of both R(+) and S(−) enantiomers of bupivacaine were studied intensively and the S(−) enantiomer (levo-enantiomer) appeared to have a safer pharmacological profile 3.
Compared to plain solutions, hyperbaric solutions are expected to provide a more predictable block with fewer side effects i.e. high block, hypotension, nausea, vomiting, and pruritus4 .
Additives are drugs added to local anaesthetics that exert direct analgesic effect and prolongs duration of sensory and motor blockade, reduces the dose of local anaesthetic needed5.
As there is still lack of clinical studies on comparison of effects of these two groups in infraumbilical surgeries, the aim of this study is to compare the anesthetic effect and hemodynamic effects of hyperbaric levobupivacaine 0.5% with hyperbaric levobupivacaine 0.5% plus fentanyl in infrumbilical surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of age group 18-60 years undergoing infraumbilical surgeries under subarchnoid block except LSCS 2.Patients willing to give written informed consent 3.Patients belonging to ASA I and II 4.Patient with height in the range of 150 cm to 175 cm.
排除标准
- •Patients with history of hypersensitivity to local anesthetics.
- •2.Subjects having any absolute contraindications for spinal anaesthesia like increased ICP, severe hypovolemia , bleeding diathesis , local site infection, neurological deficit, spinal deformity.
- •Patients with neurological or psychiatric disorders or with communication problems.
- •4.Patients on antihypertensive medications.
- •5.ASA 3/4/5 6.Pregnant women undergoing LSCS.
结局指标
主要结局
Onset of sensory block, time for maximum sensory blockade, two segment sensory regression, duration of sensory block,onset of motor blockade, maximum motor block, duration of motor block, duration of analgesia.
时间窗: Sensory blockade will be tested every 30 seconds from time of injection of drug till the | loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals | till the maximum level of sensory blockade is achieved and subsequently at 30 | mins interval until complete recovery. Motor block will be assessed every 1 minute for the first 5 min, then at 5-min intervals for next 30 | minutes and at every 30 minutes intervals until complete resolution of motor | anesthesia.
次要结局
- Hemodynamic parameters(Blood pressure, changes in heart rate)
研究者
SHIVARAJA CHANNAPPA KARAKOORA
Bangalore medical College and research institute