Comparative Study on the Effect of Fractional versus Bolus Dose of Levobupivacaine Used in Spinal Anesthesia in Patients Undergoing Lower Abdominal and Lower Limb Orthopedic Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Fall in mean blood pressure
研究概览
简要总结
Spinal anesthesia is a commonly used technique for lower abdominal and limb surgeries due to its rapid onset and cost-effectiveness. However, it often causes hemodynamic disturbances like hypotension and bradycardia. To mitigate these effects, fractional spinal anesthesia—administering the anesthetic in divided doses—has emerged as a promising technique, allowing gradual onset of sympathetic blockade and greater hemodynamic stability.
Levobupivacaine, the S(-) enantiomer of bupivacaine, is favored for spinal anesthesia due to its reduced cardiotoxicity and better hemodynamic profile. Despite extensive use, most studies evaluating levobupivacaine have focused on bolus dosing, leaving the potential benefits of fractional dosing underexplored.
This prospective randomized controlled trial aims to compare the effects of fractional versus bolus dosing of intrathecal levobupivacaine in patients undergoing lower abdominal and orthopedic limb surgeries. The primary focus is on hemodynamic stability—specifically, the incidence of significant blood pressure drops and vasopressor requirements. Secondary outcomes include onset and duration of sensory/motor blockade, highest block level, postoperative pain, and adverse events.
By investigating a safer, more stable approach to spinal anesthesia, especially for patients with cardiovascular risk, this study seeks to optimize anesthetic techniques for improved patient outcomes and reduced intraoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •o ASA physical status I or II.
- •undergoing elective lower abdominal or lower limb orthopedic surgeries.
排除标准
- 未提供
结局指标
主要结局
1. Fall in mean blood pressure
时间窗: Recorded at baseline and immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over | • Assessment will be done every 30 minutes in the postoperative period till sensory and motor variables returns back to normal
2. Total number of doses of vasopressor required
时间窗: Recorded at baseline and immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over | • Assessment will be done every 30 minutes in the postoperative period till sensory and motor variables returns back to normal
次要结局
- 1.Onset & duration of sensory & motor blockade.(2.Highest sensory block level achieved.)
研究者
Kashish Garg
PGIMER Satellite Centre Sangrur
