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临床试验/CTRI/2025/02/080510
CTRI/2025/02/080510尚未招募4 期

Comparative study of 0.5 percentage hyperbaric levobupivacaine, 0.75 percentage hyperbaric ropivacaine and 0.5 percentage hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries.

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月12日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Onset of sensory and motor block

研究概览

简要总结

Bupivacaine is the most commonly used intrathecal local anaesthetic ,but due to CNS and CVS toxicity associated with it lead to research of better alternatives for spinal anaesthesia. Studies have reported that hyperbaric 0.5% ropivacaine produce reliable subarachnoid block but of shorter duration than 0.5 % hyperbaric bupivacaine and 0.5 % hyperbaric levobupivacaine.A prospective randomized double blind study is planned to be conducted on 195 adult ASA grade I, II, III patients posted for lower limb surgeries under spinal anaesthesia after taking a written informed consent. Enrolled patients will be randomly divided into three equal groups to receive either   2.5ml of 0.5% hyperbaric levobupivacaine with , 2.5ml  of 0.75% hyperbaric ropivacaine and 2.5ml of 0.5% hyperbaric bupivacaine with 25µg fentanyl (total volume-3ml) in subarachnoid block. Patient will be observed for duration of sensory block, time of onset of sensory and motor block, maximum sensory level, time to achieve maximum sensory level, time to complete motor block, time required for complete motor regression, duration of analgesia and hemodynamic parameters. This study will help us to compare 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine and 0.5% hyperbaric bupivacaine in combination with fentanyl in terms of clinical efficacy and safety profile for use in lower limb surgeries under subarachnoid block

研究设计

研究类型
Interventional
分配方式
Other
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

  • •American Society of Anaesthesiologists (ASA) gradeI, II and III.

排除标准

  • •Patient refusal for subarachnoid block.
  • •Patients with allergy to local anaesthetic drugs or any history of anaphylacticreaction to the drugs used.
  • •Patients with coagulopathy evidenced by history and laboratory investigations.
  • •Patients with infection at injection site
  • •Patients with spinal deformities like kyphoscoliosis and scoliosis etc.
  • •Patients with history of pre-existing neurological disease.
  • •Unable to comprehend sensory and motor block.
  • •Patient’s refusal for consent.
  • •Patients with failed spinal anaesthesia and subsequent conversion to general anaesthesia.

结局指标

主要结局

Onset of sensory and motor block

时间窗: 0 min, 2min, 4min, 6min, 8min , 10min ,15min and thereafter every 15min till two dermatome regression from maximum level of sensory block occurs

次要结局

  • 1.To determine highest level and duration of sensory block.(2. Duration of motor block)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr M Rupinder Singh

Dayanand Medical College and Hospital

研究点 (1)

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