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临床试验/CTRI/2021/01/030366
CTRI/2021/01/030366已完成不适用

Comparison of analgesic efficacy of levobupivacaine and levobupivacaine with dexamethasone in lower abdominal surgeries under subarachnoid block

Guru Teg Bahadur Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Duration of effective analgesia

研究概览

简要总结

Patients will be randomly allocated to one of the two groupsusing a computer-generated random number table. Concealment will be done usingconsecutively numbered sealed opaque envelopes.

Group-LS: 12.5 mg of 0.5%isobaric levobupivacaine (2.5 ml) + normal saline(1ml)

Group-LD: 12.5 mg of 0.5%isobaric levobupivacaine (2.5 ml) + 4 mg dexamethasone (1 ml)

                The total volume of intrathecal drug will be 3.5 ml inboth the groups.

Under continuous monitoring, subarachnoid block willbe performed under all aseptic precautions as per the standard protocol.Patients will be assessed for characteristics of sensory and motor block, pain score,haemodynamic parameters and side effects.

OUTCOMEMEASURES

1.     Analgesicefficacy: Duration of effective analgesia (Time from the subarachnoidblock to the time of patient’s first complaint of pain (VAS  3).

2.     Quality of sensory block.

3.     Quality of motor block.

4.     Side effects, if any.

 Statistical Analysis:

Since it’s a pilot study thereis no hypothesis testing. Post – hoc observed power will be calculatedandiffound≥ 80% we would apply test of significance. UnpairedT-test/ Man Whitney U tests will be used to obtain the significance. A p- value< 0.05 will be considered significant.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I or II 18-65 years height 150-180 cm.

排除标准

  • Non-consenting for subarachnoid block Infection at injection site Coagulopathy Space occupying lesion Increased intracranial tension Seizure disorder, pre-existing neurological deficit, any spine deformity Hepatic and renal disease On antiarrhythmics Drug addicts and chronic alcoholic Pre-existing diabetes mellitus.

结局指标

主要结局

Duration of effective analgesia

时间窗: 6hr

次要结局

  • Quality of sensory block.(Quality of motor block.)

研究者

申办方类型
Government medical college

研究点 (1)

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