Evaluation of hyperbaric levobupivacaine (0.5%) and hyperbaric bupivacaine (0.5%) in patients undergoing infra-umbilical surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effects of Hyperbaric Levobupivacaine (0.5%) & Hyperbaric Bupivacaine (0.5%) on the onset & duration of sensory and motor block and to evaluate perioperative hemodynamic effects
研究概览
简要总结
Subarachnoid block has been a popular anesthesia techniquefor infra-umbilical and lower limb surgeries. Hyperbaric racemic bupivacaine iscommonly used for subarachnoid due to its long duration of action and combinedmotor and sensory blockade. However, the use of hyperbaric racemic bupivacainein subarachnoid block has some drawbacks. It has a high propensity to causehypotension and bradycardia following intrathecal injection, and there ispotential for catastrophic cardiac toxicity due to the high affinity ofbupivacaine to cardiac myocytes. Levobupivacaine, an amide local anestheticwhich is the isolated S-enantiomer of bupivacaine.
Racemic bupivacaine is an equimolar mixture of dextro andlevobupivacaine. Levobupivacaine has a lower affinity for cardiac sodiumchannels and greater plasma protein binding affinity compared with the dextroisomer; thus, reducing the risk of cardio-toxicity.
Levobupivacaine also results in earlier motor recovery compared withracemic bupivacaine. These advantages make levobupivacaine an attractivealternative to racemic bupivacaine for sub arachnoid block. However itsclinical efficacy in subarachnoid block should be known first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- 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
- •Age group 18-60 years of either age.
- •Patients with ASA grade I and II 3) patients with average height (>5 feet).
- •All patients undergoing infra-umbilical surgeries.
排除标准
- •Patient refusal or not giving consent.
- •Patients with the Neurological disease, bleeding diathesis, Coagulopathy disorders.
- •Patients with spine/Neurological deformities, 4) Local Skin infections or disease.
- •History of drug allergy.
- •Patients on tranquilizers, hypnotics, sedatives and other psychotropic drugs.
- •Severe liver or kidney diseases.
- •ASA grade III and IV, V.
结局指标
主要结局
To evaluate the effects of Hyperbaric Levobupivacaine (0.5%) & Hyperbaric Bupivacaine (0.5%) on the onset & duration of sensory and motor block and to evaluate perioperative hemodynamic effects
时间窗: Immediately after induction till 180 minutes.
次要结局
- To evaluate the post-operative analgesia.(To evaluate the occurrence of side effects & complications, if any.)