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临床试验/NCT05429567
NCT05429567已完成1 期

Effectiveness of Patient-Controlled Intravenous Analgesia (PCIA) With Fentanyl Background Infusion for Total Hip Replacement

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Fentanyl Background

研究概览

简要总结

To enhance post-operative pain management, patient-controlled intravenous analgesia (PCIA) has been employed. The fentanyl background PCIA therapy was created to solve the limitations of IV-based PCIA, such as programming errors, mobility limitations, and the risk of needle stick injuries. The goal of this trial was to observe how fentanyl patient-controlled intravenous analgesia pump (PCIA) and background infusion is worked in patients with post-total hip replacement analgesia.

详细描述

Significant efforts to enhance the treatment of postoperative pain have resulted in the formulation and implementation of pain management guidelines, as well as the introduction of acute pain services in several hospitals during the last two decades.

Recent research, however, suggests that postoperative pain is still poorly controlled .

Hip replacement procedures are prevalent among the elderly, and they are significantly more painful .

The patient may suffer greatly as a result of the pain, which can also affect physiological functioning caused by hormonal changes caused by sympathetic nervous system activation .

Anaesthesiologists and patients alike are concerned about pain management following major surgery. It should also be mentioned that every pain management medication has certain side effects, especially when an opioid is utilized .

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
Single (Participant)

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with total fracture of Hip bones

排除标准

  • History of mental or neurological complaints,
  • Opioid and local anaesthetic allergies,
  • Opioid tolerance,
  • Smoking history,
  • local infection,
  • cemented total hip arthroplasty (THA), revision THA,
  • preoperative DVT,
  • renal failure,
  • bleeding tendency due to anticoagulant therapy

研究组 & 干预措施

fentanyl infusion Group

Experimental

According to the body weight, 2 ug/kg fentanyl was diluted to 100 ml with normal saline. with rate of 2 mL/h infusions, 10 min lockout time and Initial PCIA analgesia regimen consisting of a 0.5 mL bolus was commenced to be given to the patients postoperative with evaluation the pain

干预措施: Fentanyl (Drug)

NO fentanyl infusion Group

Experimental

All patients underwent combined spinal and epidural anesthesia (CSEA) with 2 ml of 0.5 % hyperbaric bupivacaine only

干预措施: Fentanyl (Drug)

结局指标

主要结局

Fentanyl Background

时间窗: from 0 hours to 36 hours after the completion of the operation

Effectiveness of Patient-Controlled Intravenous Analgesia (PCIA) With Fentanyl Background Infusion for Total Hip Replacement

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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