A Comparative Study Of Hyperbaric Ropivacaine 0.75% Vs Hyperbaric Bupivacaine 0.5% For Spinal Anaesthesia In Infraumbillical Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effects of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on onset, duration, time to maximum sensory and motor block.maximum level of sensory block, time to 2 segment regression of sensory block
研究概览
简要总结
Spinal anaesthesia or subarachnoid block is a widely used regionalanaesthetic technique in a variety of infraumbillical, perineal and lower limbsurgeries. It is achieved by injection of local anaesthetic into subarachnoidspace mainly in the lumbar area.
Itresults in sympathetic, sensory and motor blockade depending the concentration,volume and baricity of the drug injected. Ropivacaine is an amide local anaesthetic which is produced as a pure Senantiomer. The S enantiomers are less neurotoxic and cardiotoxic compared to Renantiomers and racemic mixture forms of amide pipecoloxylidide localanaesthetics. Bupivacaine is considered the gold standard longacting local anaesthetic for most regional anaesthetic procedures such assubarachnoid block.
Ropivacaine compared to bupivacaine has a better safety profile but producesa lower grade of motor block and has a shorter duration of action.Studies have been done comparing the clinicaleffectiveness of 0.75% plain ropivacaine with 0.5% heavy bupivacaine whichshowed a similar quality of block with late onset and shorter duration ofsensory and motor blockade in 0.75% plain ropivacaine. This study aims tocompare the block characteristics of 0.75% heavy ropivacaine with 0.5% heavybupivacaine in infraumbillical surgeries,
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •2.Patient willing to give informed consent 3.ASA grade 1 and 2 4.Patients undergoing infraumbilical surgeries under spinal anaesthesia.
排除标准
- •1.Patients refusing to give informed consent 2.Patients undergoing emergency surgeries 3.Patients with history of allergy to the study drugs 4.Pregnant women 5.Patients ASA grade 3,4,5 6.Patients under 18 years and over 60 years of age.
- •7.Infection at the site of injection 8.Sepsis 9.Spinal deformities 10.Severe hypovolemia 11.Coagulopathies 12.Raised intracranial tension.
结局指标
主要结局
To compare the effects of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on onset, duration, time to maximum sensory and motor block.maximum level of sensory block, time to 2 segment regression of sensory block
时间窗: baseline, every minute upto 10 minutes, every 10 minutes upto end of surgery
次要结局
- To compare the effects of the 2 drugs on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation of oxygen & the incidence of adverse effects if any.(baseline, every minute upto 10 minutes, every 10 minutes upto end of surgery)