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临床试验/NCT02026050
NCT02026050已完成4 期

Phase 4 Study of Comparison of Postoperative Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus Blockade for Arthroscopic Shoulder Surgery

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
75
试验地点
1
主要终点
analgesic consumption

研究概览

简要总结

the aim of this study was to investigate the analgesic efficacy of intra articular dexamethasone administration for arthroscopic shoulder surgery.

详细描述

shoulder surgery can be very painful and interscalene brachial plexus block is the gold standard in the management of acute pain after shoulder surgery. various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexamethasone are frequently used for this purpose. dexamethasone has also been found the prolong the duration of lidocaine axillary blocks and intravenous regional anaesthesia. intraarticular administration of medicines can be used for management of joint pain and opioids , local anaesthetics and dexamethasone are used for this purpose.In addition, there are no studies available to compare the different treatment methods used in clinical practice directly.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •between 18-65 years
  • •arthroscopic shoulder surgery
  • •no known allergies to drugs
  • •ASA 1-2 patients

排除标准

  • •history of diabetes
  • •history of chronic pain treatment
  • •pregnancy
  • •severe bronchopulmonary disease
  • •systemic glucocorticoid use

研究组 & 干预措施

interscalene dexamethasone

Active Comparator

interscalene brachial plexus was preoperative performed 30 ml 0.5 % bupivacaine added 2 ml 8mg dexamethasone and after surgery 10 ml serum phsyologic administration for intraarticular

干预措施: interscalene dexamethasone (Procedure)

serum phsyologic

Placebo Comparator

interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular

干预措施: serum phsyologic (Procedure)

intraarticular dexamethasone

Active Comparator

interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2 ml serum phsyologic and after surgery 2 ml 8 mg dexamethasone+ 8 ml serum phsyologic administration for intraarticular

干预措施: intraarticular dexamethasone (Procedure)

结局指标

主要结局

analgesic consumption

时间窗: postoperative 1 day

morphine consumption (patient controlled analgesia procedure) was recorded

次要结局

  • visual analog scale(postoperative 1 day)

研究者

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

Fatih Mehmet Kurt

resident

TC Erciyes University

研究点 (1)

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