COMPARISON OF 0.5% BUPIVACAINE AND 0.5% LEVOBUPIVACAINE UNDER SPINAL ANESTHESIA IN UROLOGICAL SURGERIES
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Time of onset of Sensory blockade
研究概览
简要总结
Background:Spinal anesthesia is a widely preferred technique for lower abdominal and urological surgeries due to its rapid onset and effective sensory and motor blockade. Among the commonly used agents for neuraxial blockade are bupivacaine and its S-enantiomer, levobupivacaine. While both are amide-type local anesthetics, levobupivacaine was developed to reduce the cardiotoxicity and neurotoxicity associated with racemic bupivacaine. Despite their widespread use, comparative data on the efficacy and safety of these procedures in urology remain limited.
Objective:To compare the efficacy and safety of 0.5% hyperbaric bupivacaine versus 0.5% isobaric levobupivacaine in spinal anesthesia for patients undergoing elective urological surgeries.
Method:This is a prospective, randomized clinical study. Patients scheduled for elective urological surgeries will be randomly assigned to receive either 0.5% hyperbaric bupivacaine or 0.5% hyperbaric levobupivacaine via spinal anesthesia. Parameters assessed will include onset time, peak block level, duration of sensory and motor blockade, intraoperative hemodynamic changes, and incidence of adverse effects. All clinical and safety parameters will be systematically recorded and analyzed.
Outcome:The study will determine the comparative onset and duration of anesthesia, hemodynamic stability, incidence of side effects, and overall clinical efficacy of the two drugs in urological surgeries.
Significance:By providing head-to-head data on bupivacaine and levobupivacaine in the specific context of urological procedures, this study aims to guide anesthetic drug selection, particularly for patients with cardiovascular risk factors or requiring tailored anesthetic plans. The findings could contribute to safer and more effective spinal anesthesia practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 and 75 years will be included.
- •Only those with ASA (American Society of Anesthesiologists) physical status classification I or II (indicating healthy individuals or those with mild systemic disease) will be considered.
- •Patients scheduled to undergo elective urological surgery under spinal anesthesia will be eligible.
- •Written informed consent will be obtained from all participants.
排除标准
- •Patients with a known allergy to amide local anesthetics will be excluded.
- •Individuals with severe cardiovascular, hepatic, renal, or neurological disorders will not be eligible.
- •Patients with contraindications to spinal anesthesia—such as spinal deformities, neurological disorders, or increased intracranial pressure—will be excluded.
- •Those with blood clotting disorders or currently on anticoagulant therapy will not be included.
- •Patients who refuse to participate in the study will be excluded.
- •Individuals with class II obesity (BMI MORE THAN EQUAL TO 30 kgm²) will be excluded.
- •Pregnant or lactating women will not be eligible to participate.
结局指标
主要结局
1. Time of onset of Sensory blockade
时间窗: 1. Time of onset of Sensory blockade- 5 hours | 2. Time of onset of Motor blockade- 5 hours | 3. Duration of sensory and motor block- 5 hours | 4. Cardiovascular side effects associated with both the drugs- 5 hours
2. Time of onset of Motor blockade
时间窗: 1. Time of onset of Sensory blockade- 5 hours | 2. Time of onset of Motor blockade- 5 hours | 3. Duration of sensory and motor block- 5 hours | 4. Cardiovascular side effects associated with both the drugs- 5 hours
3. Duration of sensory and motor block
时间窗: 1. Time of onset of Sensory blockade- 5 hours | 2. Time of onset of Motor blockade- 5 hours | 3. Duration of sensory and motor block- 5 hours | 4. Cardiovascular side effects associated with both the drugs- 5 hours
4. Cardiovascular side effects associated with both the drugs
时间窗: 1. Time of onset of Sensory blockade- 5 hours | 2. Time of onset of Motor blockade- 5 hours | 3. Duration of sensory and motor block- 5 hours | 4. Cardiovascular side effects associated with both the drugs- 5 hours
次要结局
- 1. Cardiovascular side effects(2. Other post-operative complications)
研究者
Dr Abhijith A
Healthway Hospitals Pvt Ltd