跳至主要内容
临床试验/CTRI/2025/04/085255
CTRI/2025/04/085255尚未招募4 期

Comparative study between magnesium sulphate versus dexamethasone as an adjuvant to 0.5 percent bupivacaine in supraclavicular brachial plexus block.

Sabyasachi Mohapatra1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare and study the onset and duration of sensory and motor blockade of magnesium sulphate and dexamethasone as an adjuvant to 0.5% Bupivacaine in supraclavicular brachial plexus block

研究概览

简要总结

It is a prospective, randomised, double blinded comparative study to compare magnesium sulphate versus dexamethasone as Ana adjuvant to 0.5% Bupivacaine in supraclavicular brachial plexus block.

60 patients planned for upper limb surgeries below the shoulder will be divided into two groups of 30 patients each: Group A(dexamethasone) and Group B(magnesium sulphate)

Objectives include

To compare and study the onset of sensory blockade and motor blockade in both study groups.

To compare and study the duration of sensory analgesia and motor blockade in both study groups.

To compare the duration of post operative analgesia in both study groups.

To observe any side effects of both the drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor 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

  • ASA grade 1 and 2 fit patients.
  • Patients aged between 18-60 years of age.
  • Both male and female gender.
  • 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 who are not willing to participate in the study.
  • Patients with ASA grade 3 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 who are posted for emergency procedures.
  • Patients with bleeding disorders and those on anticoagulant therapy.
  • Infection at site of block.
  • Neuro deficit involving brachial plexus.
  • Pregnant women.
  • Patients with psychiatric, neurological, neuromuscular or cardiovascular disease or impaired hepatic or renal function.

结局指标

主要结局

To compare and study the onset and duration of sensory and motor blockade of magnesium sulphate and dexamethasone as an adjuvant to 0.5% Bupivacaine in supraclavicular brachial plexus block

时间窗: The sensory block will be evaluated by pin prick sensation and motor block will be assessed with the help of modified bromage scale after injection of study drugs. Vital parameters will be monitored every 5 mins for first 15 mins and every 15 mins till the end of surgery

次要结局

  • To compare the duration of post operative analgesia in both study groups & observe any side effects of both the drugs(Duration of analgesia will be assessed post surgery & time to rescue analgesia will be assessed 2 hourly after surgery until intervention is required)

研究者

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

Dr Sabyasachi Mohapatra

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

研究点 (1)

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