跳至主要内容
临床试验/NCT04194320
NCT04194320已完成不适用

Nalbuphine Versus Dexamethasone as an Adjuvant to Lidocaine / Bupivacaine Mixture in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries

Zagazig University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Duration of postoperative analgesia

研究概览

简要总结

Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of dexamethasone or nalbuphine as adjuvants to local anesthetics in supraclavicular brachial plexus block for upper limb surgeries.

详细描述

Upper-limb surgeries can be performed under either general or regional anesthesia.However, regional anesthesia has the advantages of long-lasting pain relief & avoidance of airway instrumentation.Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to local anesthetics mixture (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in Ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries below the level of the shoulder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient acceptance.
  • American Society of Anesthesiologists (ASA) I and (ASA) II.
  • Age 21-60 years old.
  • Both gender.
  • Accepted mental state of the patient.
  • Unilateral upper limb surgeries below the level of the shoulder.

排除标准

  • Patient refusal.
  • Peripheral neuropathy.
  • Pathological coagulopathy.
  • Infection at the injection site.
  • History of active substance abuse.
  • Untreated pneumothorax.
  • Disturbed conscious level.
  • An allergy to local anesthetics or nalbuphine or dexamethasone.
  • Planned for receiving general anesthesia during the same operation for any cause.

结局指标

主要结局

Duration of postoperative analgesia

时间窗: First 24 hours after surgery

Time between onset of sensory block to the first report of postoperative pain at the surgical site that has a VAS "visual analogue score" ≥ 4.

次要结局

  • The total opioid consumption(First 24 hours after surgery)
  • post operative pain score "Visual Analogue Score"(First 24 hours after surgery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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