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临床试验/NCT03372486
NCT03372486已完成不适用

Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on the Anti-nociceptive Criteria of Post-operative Opioid in Orthopedic Upper Limb Surgeries

Mansoura University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年12月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Effect of ultra-low dose naloxone on the post operative opioid

研究概览

简要总结

Effective post-operative pain control can reduce patient morbidity and affect the patient outcome. Brachial plexus block is one of them, a popular and widely employed regional nerve block technique for perioperative anesthesia and analgesia for surgery of the upper extremity.

Different drugs have been used as adjuvants with local anesthetics in brachial plexus block to achieve quick, dense and prolonged block like Morphine, Pethidine, Clonidine, Dexmedetomidine.

Naloxone is opioid antagonists which could selectively block the excitatory effects of opioids. it release endorphins and also displace endorphins from receptor site .it also reduce the opioid induced side effects, such as vomiting, nausea, pruritus, and respiratory depression.

详细描述

The aim of this study is to evaluate the effect of ultra-low dose of naloxone when added to bupivacaine %.05 in supraclavicular brachial plexus block in orthopedic upper limb surgery and if it enhances the anti-nociceptive effect of post-operative opioid

Effect of naloxone on anti-nociceptive criteria of post -operative opioid will be estimated by detecting the interval between each analgesic dose of post-operative opioid.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) physical state class Ι and II
  • Elective upper limb orthopedic surgery (hand, forearm and elbow)
  • Duration of surgery ≤180 min
  • BMI ≤30 kg/m2

排除标准

  • History of allergy to the drug of the study.
  • Coagulation disorders
  • Infection at the puncture site.
  • Pregnancy
  • Opioid abuse.
  • Abuse of tranquilizers

研究组 & 干预措施

Bupivacaine plus naloxone

Active Comparator

Patients will receive brachial plexus block using bupivacaine plus naloxone.

干预措施: Bupivacaine plus naloxone (Drug)

Bupivacaine

Placebo Comparator

Patients will receive brachial plexus block using bupivacaine.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Effect of ultra-low dose naloxone on the post operative opioid

时间窗: for 48 hours after surgery

by estimate the analgesic requirements of opioids and the interval between each opioid dose in 48 hour post operative

次要结局

  • Duration of sensory block(For 48 hours after surgery)
  • Duration of motor block(For 48 hours after surgery)
  • Onset time of sensory block(For 48 hours after surgery)
  • Onset time of motor block(For 48 hours after surgery)
  • Severity of post-operative pain(For 48 hours after surgery)
  • 1st time of analgesic request(For 48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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