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临床试验/CTRI/2024/05/067262
CTRI/2024/05/067262已完成4 期

A prospective study of comparison of analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm surgeries.

Rashmi Kelkar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To compare the analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm surgeries.

研究概览

简要总结

It is a prospective, randomized, double blinded comparative study to compare the analgesic efficacy of perinueral dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm surgeries.

Parameters that will be compared between the two groups will be the onset and duration of action of sensory and motor blockade, duration of analgesia and time to rescue analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA grade 1 and ASA grade 2 fit patients.
  • 2.Patients posted for upper limb surgeries below shoulder
  • Hemodynamically stable patients with all routine investigations within normal limits.
  • Written informed consent from the concerned patients.

排除标准

  • Patients whose parents are not willing to participate in the study.
  • Patients with ASA grade III and above physical status.
  • Patients who are aged more than 60 years and less than 18 years of age
  • Patients with known allergy to the study drugs.
  • Patients with bleeding disorders and those on anticoagulant therapy
  • Infection at site of block
  • Neurodeficit involving brachial plexus
  • Pregnant women
  • Patients with psychiatric behavior.

结局指标

主要结局

To compare the analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm surgeries.

时间窗: After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and 10 mins after surgery.

次要结局

  • To compare the analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone & paracetamol after supraclavicular block in patients undergoing forearm surgeries.(Duration of analgesia will be assessed post surgery once the effects of the block decrease & time to rescue to analgesia will be assessed 2 hours after surgery & hourly until intervention is required)

研究者

发起方
Rashmi Kelkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rashmi Kelkar

Dr. D.Y.Patil Medical College, Hospital and Research Centre

研究点 (1)

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