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临床试验/CTRI/2025/07/090371
CTRI/2025/07/090371尚未招募不适用

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

Dr Kashish Garg1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月1日最近更新:

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

发起方
Dr Kashish Garg
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kashish Garg

PGIMER Satellite Centre Sangrur

研究点 (1)

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