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临床试验/NCT03377907
NCT03377907已完成不适用

Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine

Assiut University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年2月1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
66
试验地点
1
主要终点
pain assessment

研究概览

简要总结

fractures of upper limb induce much pain . A lot of modalities are available to alleviate pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective and attractive options

详细描述

Fractures of the forearm are extremely common, Pain relief is of utmost importance in forearm fractures which may need manipulation immediately for reduction followed by operative intervention

The characteristic features of ideal analgesia during reduction are determined by safety, simplicity, affectivity and costs. Giventhe logistic difficulty of providing such anesthesia to such large number of patients simpler alternatives to conventional anesthesia have been tried. Hematoma Block alone, Hematoma Block with sedation, Bier's Block (Intravenous regional anesthesia), regional nerve blocks, sedation have been compared to general anesthesia to evaluate the efficacy, effectiveness, safety in treating such patients

Amongst various techniques, HB and IVRA are attractive options. However, while HB has been demonstrated to be safe simple and has been used effectively for treatment of radius fractures in ER and for immediate pain relief it doesn't provide muscular relaxation and may not be sufficient for any operative intervention

IVRA is suitable for operations of the distal extremities, in situations where it is safe and easy to apply an occlusive tourniquet. The primary advantages of IVRA are its simplicity, reliability, and cost-effectiveness. . It is a regional anesthetic technique that is easy to perform, with success rates varying between 94% and 98%.For these reasons, it remains a popular choice among anesthesiologists.

A combination of blocks is usually done to overcome the deficiencies of individual blocks and to improve operating conditions or to prolong post operative analgesia. However the use of dual technique of IVRA and HB with local anesthetic only offered near absence of post operative analgesia

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
Double (Participant, Care Provider)

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

  • All patients aged more than 18 years old.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Patients scheduled for closed fracture of distal upper extremity within 7 days, requiring open or closed reduction and internal fixation.
  • Patients scheduled for procedure lasting less than 90 minutes.

排除标准

  • Patients having cardiovascular co-morbidities.
  • Compound or contaminated fracture.
  • Peripheral vascular disease, sickle cell disease or coagulation disorders.
  • Allergy to the local anesthetics or to the drugs used in the study.

研究组 & 干预措施

Ketamine in hematoma block

Active Comparator

Ketamine used in hematoma block

干预措施: ketamine in hematoma block (Drug)

ketamine intravenous anesthesia

Active Comparator

ketamine used in local intravenous anesthesia

干预措施: ketamine in local intravenous anesthesia (Drug)

lidocaine intravenous anesthesia

Active Comparator

2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.

干预措施: Lidocaine Hydrochloride (Drug)

结局指标

主要结局

pain assessment

时间窗: 24 hours

pain will be assessed by numerical rating scale

次要结局

  • analgesia requirement(24 hours)

研究者

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

Mohammed mamdouh mohammed mahmoud

Dr

Assiut University

研究点 (1)

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