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临床试验/NCT06720506
NCT06720506尚未招募4 期

Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine As a Postoperative Analgesia in Lower Limb Surgeries

Assiut University0 个研究点目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
100
主要终点
first request of rescue analgesia

研究概览

简要总结

Postoperative pain management has been a major challenge and there has been great interest about it ., there have been persistent efforts to bring out the best possible analgesic technique with the least side effects. The popularity of lower limb surgeries owing to its higher incidence, orthopedic and vascular surgerise. Inadequate postoperative pain relief is associated with undesirable side effects resulting in chronic persistent pain, delayed recovery Concern about opioid has powerful effect in relief post operative pain.

the aim of this study is to Compare between fentanyl intrathecal and nalbuphine IV as a postoperative analgesia in lower limb surgeries

详细描述

Fentanyl, a potent lipid-soluble opioid which was first synthesized more than 40years ago, is still the most popular opioid used as post operative analgesia t. Fentanyl given intrathecally use in many acute and chronic pain conditions. inspite of its side effects fentanyl remains the mainstay of anesthesiologists in post operative period analgesia.

Anesthetic methods of Lower limb surgery such as orthopedic and vascular surgeries, for example in the use of local infiltration, spinal anesthesia, caudal anesthesia, or general anesthesia Among them, spinal anesthesia is commonly used for lower limb surgery which does not need a sophisticated machine and which has been performed for years before anesthetic equipment such as mechanical ventilators and monitoring devices was produced. The development of new local anesthetic agents, the use of opioids, and an interest in acute and chronic pain management have universalized spinal anesthesia. Immediate pain is very severe in lowerlimb surgery and difficul to control. Moreover, due to the short hospitalization period, there is a limit in the application of patient-controlled analgesia that permits patients to treat pain by directly activating doses of opoids .

Nalbuphine...

Nalbuphine is an agonist-antagonist opioid and provides prolonged duration of analgesia with

fewer side effects of fentanyl such as pruritus, nausea, and vomiting.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • male and female pt between 18 and 600 year
  • pt with lower limb surgeries with no. Indication for general anathesia
  • patient with no contraindication for spinal anatthesia

排除标准

  • pt who refuses
  • pt with hypersensivity to any drug
  • pt addicts opiods
  • chronic use of opiod
  • Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.

研究组 & 干预措施

group F

Experimental

patients will received intrathecal with dose 10-20ug

干预措施: fentanyl (Drug)

group N

Experimental

Nalbuphine will given IV as shot in. Dose 1mg /kg

干预措施: Nalbuphine (Drug)

结局指标

主要结局

first request of rescue analgesia

时间窗: 24 hours

Duration of analgesia until first analgesic request

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Khaled Helmy Abdelbasser

resident doctor at Anathesia and icu department Faculty of Medicine, Assiut University

Assiut University

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