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临床试验/CTRI/2024/04/065128
CTRI/2024/04/065128尚未招募4 期

Comparative Study Of 0.5% Levobupivacaine With And Without Fentanyl In Ultrasound Guided Supraclavicular Brachial Plexus Block: A Randomised, Prospective Study

Smitakshi Das1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年4月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
To compare the duration of sensory block in each group

研究概览

简要总结

This is a prospective, double-blind, randomised control study to be conducted in the Orthopaedic operation theatre under the Department of Anaesthesiology and Critical care, GMCH. The study will be carried out on adult patients of both sexes, posted for elective upper limb orthopaedic surgery. The aim of this study is to determine the efficacy of 0.5% levobupivacaine alone and 0.5%levobupivacaine with   fentanyl in USG guided supraclavicular brachial plexus block.The primary objective is to compare the duration of sensory block in each group. The secondary objectives are onset of sensory block, onset and duration of motor block, duration of analgesia, hemodynamic changes following block, side effects and 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

  • ASA grade 1 and 2
  • Patient posted for elective orthopaedic elbow, forearm and hand surgeries under USG guided supraclavicular brachial plexus block
  • Patients giving consent to participate in the study.

排除标准

  • Coagulation disorders and patient on anticoagulants
  • Infection at site of injection
  • History of anaphylaxis to local anaesthetics and allergy to the study drugs
  • Patients with peripheral neuropathy.
  • Patients on chronic analgesic medications
  • Patients with contralateral phrenic nerve palsy.
  • Block failure or partial blocks
  • Pregnant and lactating patients.

结局指标

主要结局

To compare the duration of sensory block in each group

时间窗: 24hrs

次要结局

  • Onset of sensory block and motor block(30mins)
  • Duration of motor block(till full recovery of motor function)
  • Duration of analgesia(24 hours)
  • Hemodynamic changes following block(During intraoperative period)
  • Side effects and complications(24 hours)

研究者

发起方
Smitakshi Das
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Smitakshi Das

Gauhati Medical College and Hospital

研究点 (1)

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