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临床试验/CTRI/2020/05/025082
CTRI/2020/05/025082尚未招募3 期

A comparative study of the effect of Dexmedetomidine and Nalbuphine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block: A prospective randomized, double blind study

Jyoti Mala1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年11月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1. Onset of motor block

研究概览

简要总结

Supraclavicular brachial plexus blockade  is the common approach to provide surgical anesthesia of upper limb, was first described by Kulenkampff in 1911.(1) It is an efficient regional anesthetic technique for upper limb surgeries. Which is a reliable, alternative to general anesthesia for certain group of patients as it is devoid of undesired effects of general anesthesia and stress of laryngoscopy. The postoperative period is also free from pain, nausea, vomiting, and respiratory depression. Adjuvants are added to local anaesthetics to improve various block characteristics in terms of onset of action ,duration of analgesia with lesser adverse effect. Various study has been done using different types of adjuvants in different combination of local anaesthetics for various nerve blocks. In our study we will use levobupivacaine LA because it is relatively safe in terms of less cardiac and neurotoxic adverse effects. Dexmedetomidine is a highly selective an alpha 2 agonist which, when used as an adjuvant , prolongs the duration of action  without causing respiratory depression. Nalbuphine is recently introduced opioid agonist-antagonist. Unlike other opioids it has got ceiling effect. Furthermore,use  of ultrasound (US) has significantly improved the quality of nerve blocks by direct visualization of nerves and related anatomical structures, needle trajectory and spread of local anesthetics (LAs) during injection [2-7]. In addition, US guidance increases success rate, minimizes LAs volume needed for effective nerve block, and avoids potential complications such as intraneural or intravascular injection [2,4,5]. In this study, we plan to compare the efficacy of dexmedetomidine and nalbuphine as an adjuvant to levobupivacaine in ultrasound guided supraclavicular brachial plexus block.

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for upper limb surgery of either side
  • Patients of ASA physical status 1 & 2
  • Patients between 18-50 years of age of either sex
  • Patients able to comprehend and willing to participate.

排除标准

  • Patient’s refusal to participate
  • Patients of ASA physical status3 & 4
  • Any allergy to local anaesthetics
  • Coagulation disorders
  • Infection at the site of intervention
  • History of any underlying cardiac, renal or hepatic dysfunction •Pregnant patient.

结局指标

主要结局

1. Onset of motor block

时间窗: 3 months

2. Onset of sensory block

时间窗: 3 months

3. Duration of analgesia

时间窗: 3 months

次要结局

  • 1. Hemodynamic stability(2. Side effects)

研究者

发起方
Jyoti Mala
申办方类型
Government medical college

研究点 (1)

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