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