跳至主要内容
临床试验/CTRI/2021/08/036003
CTRI/2021/08/036003尚未招募不适用

Comparison of 0.5% levobupivacaine alone and 0.5% levobupivacaine with butorphanol given intrathecally in infraumbilical surgeries; a randomised control trial

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月30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
60
试验地点
1
主要终点
Onset, duration of sensory and motor blockade, peak height, two segment regression time, time for first rescue analgesia will be assessed

研究概览

简要总结

Spinal anaesthesia was the first major regional technique introduced into the clinical practice.  Spinal anaesthesia is a safe, reliable and also inexpensive technique.  It has the advantage of providing surgical anaesthesia with prolonged post operative pain relief with use of various local anaestheticagents. It also blunts the intra-operative, autonomic, somatic and endocrine responses. Spinal anaesthesia has a faster onset and effective sensory and motor blockade. Spinal anaesthesiawas first performed in 1898 by August Bier. From then on it has been practiced extensively.1

Local anaesthetics interrupt neural conduction by inhibiting the influx of sodium ions through channels or ionophores within neuronal membranes. The molecular structure of all local anaesthetics consists of 3 components, a lipophilic aromatic ring, an ester or amide linkage and tertiary amine. Local anaesthetics are classified as short acting, intermediate and long acting. This is primarily due to differences in their affinity for protein. Bupivacaine most common LA used for regional anaesthesia but it has serious side effects like cardiac and neurotoxic.

Levobupivacaine, the pure S (-) enantiomer of the racemic Bupivacaine is a long acting amide local anaestheticwhich produces differential neuraxial block. It was synthesized aiming at finding local   bupivacaine but without its hazards as cardiac and central nervous system toxicity.  Levobupivacaine exerts its pharmacological action through reversible blockade of neuronal sodium channels.  It binds to the intracellular portion of sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. The pka of levobupivacaine is 8.1, similar to the pka of the racemic bupivacaine.2

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
19.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologist (ASA) grade 1 or 2 Posted for surgeries of lower abdomen and lower limb.

排除标准

  • Refusal for procedure Obesity (BMI>30) Any neuropathy Any allergy to local anesthetic Contraindication to spinal anesthesia.

结局指标

主要结局

Onset, duration of sensory and motor blockade, peak height, two segment regression time, time for first rescue analgesia will be assessed

时间窗: day1

Efficacy of Butorphanol as an adjuvant to levobupivacaine .

时间窗: day1

次要结局

  • sensory and motor onset(day 1)

研究者

发起方
Rohilkhand Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

Loading locations...

相似试验

Comparison of two drugs in anesthesia in abdominal... | 临床试验