Comparative evaluation of intrathecal anaesthesia with hyperbaric (0.5%)Levobupivacaine (FDC-fixed dose combination)with Fentanyl and hyperbaric (0.5%) Levobupivacaine (reconstituted )with Fentanyl in patients undergoing infra-umbilical surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Each participant in the study will be assessed for following Primary outcome parameters are as follows :-
研究概览
简要总结
This study is planned in context that hyperbaric Levobupivacaine ( fixed dose combination) is recently introduced in clinical use and there are limited number of comparative clinical studies available to compare the sensory /motor block efficacy , hemodynamic profile and complication of fixed dose hyperbaric levobupivacaine vs fixed dose hyperbaric bupivacaine.
The primary limitation of earlier comparative studies is use of mixed dose hyperbaric Levobupivacaine because hyperbaric property is due to addition of dextrose in isobaric levobupivacaine.
so, the difference in the spinal charactiestics may have been in part related to the difference in baracity and dextrose concentration as well as constitution of hyperbaric solution..
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Adult patients of the American Society of Anesthesiologists physical status I and II, scheduled to undergo infra-umbilical surgery under spinal anaesthesia will be select Informed consent.
排除标准
- •Patients with uncontrolled hypertension, Neurologic disease, left ventricular dysfunction and coagulation Disorders.
- •Pregnancy Hypersensitivity to amide local anesthetics.
结局指标
主要结局
Each participant in the study will be assessed for following Primary outcome parameters are as follows :-
时间窗: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
1.Onset of sensory block (min.)
时间窗: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
2.Duration of sensory block (min.)
时间窗: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
5.Duration of analgesia (min.)
时间窗: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
3.Onset time of motor block (min.)
时间窗: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
4.Total duration of motor block (min.)
时间窗: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
次要结局
- Hemodynamics (HR, RR, SBP, DBP, MAP, SP02)Vitals