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临床试验/CTRI/2023/09/057703
CTRI/2023/09/057703尚未招募2/3 期

A study to compare the effect of intravenous versus perineural dexamethasone on random blood sugar in patients undergoing upper limb surgery under supraclavicular brachial plexus block

Sri Guru Ram Das Institute of Medical sciences and Research1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年9月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
Difference in blood sugar levels at baseline & after four hours of administration of

研究概览

简要总结

Background: Brachial plexus block is the preferred choice of anaesthesia for upper limb surgeries. Local anaesthetics like lignocaine and bupivacaine are used to provide analgesia and anaesthesia. Bupivacaine is the most commonly used local anaesthetic. Various adjuvants like clonidine, dexamethasone, opioids are used to prolong regional blockade, decrease the dosage of local anaesthetic required, shorten the onset time of block and prolong the duration of post-operative analgesia. Dexamethasone has been used as a perineural adjuvant as well as intravenous analgesic and because of its glucocorticoid properties it may cause hyperglycaemia.  Objectives: To compare the difference in blood sugar levels after the administration of dexamethasone by the perineural and intravenous route in supraclavicular brachial plexus block in non-diabetic patients undergoing upper limb surgeries. Material and methods: Total of 105 patients will receive USG guided supraclavicular brachial plexus block with 25mL of 0.5% bupivacaine. They’ll be randomly allocated to one of the three study groups of 35 each. Group I: 0.1mg/kg dexamethasone diluted in 2 mL normal saline (NS) (perineural) + 100 mL NS (Intravenous); Group II: 2 mL NS (perineural) + 0.1 mg/kg dexamethasone in 100mL NS (Intravenous); Group III: 2mL NS (perineural) + 100mL NS (Intravenous). Total volume given perineurally will be 27ml. Maximum dose of dexamethasone to be used will be 6mg. Random blood sugar will be measured at baseline (T0) and then 2, 4, 8, and 24 hours after T0. Expected Benefits: This study will help us to evaluate the effect of dexamethasone on random blood sugar levels in supraclavicular block when given intravenous vs perineurally.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
15.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients in class ASA I and II 2.Surgery planned under supraclavicular block 3.Non-Diabetic Patients.

排除标准

  • Patient refusal
  • Infection at the site of injection
  • Contraindications to brachial plexus block
  • Pregnancy
  • Patient on anticoagulants
  • Patient on chronic/acute steroid therapy
  • Perioperative dextrose infusions
  • HbA1c >5.5
  • Weight of the patient <40kgs and >100kgs.

结局指标

主要结局

Difference in blood sugar levels at baseline &amp; after four hours of administration of

时间窗: Before performing supraclavicular brachial plexus block then at 4hrs.

dexamethasone by the perineural and intravenous route

时间窗: Before performing supraclavicular brachial plexus block then at 4hrs.

次要结局

  • Blood sugar levels at 2,4,8 & 24 hours after dexamethasone administration.(Duration of analgesia of the three groups)

研究者

发起方
Sri Guru Ram Das Institute of Medical sciences and Research
申办方类型
Research institution and hospital

研究点 (1)

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