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临床试验/CTRI/2025/02/080579
CTRI/2025/02/080579进行中(未招募)4 期

TO COMPARE THE EFFICACY OF HYPERBARIC ROPIVACAINE 0.75% VS HYPERBARIC BUPIVACAINE 0.5% ON MOTOR RECOVERY AND POSTOPERATIVE AMBULATION AFTER SPINAL ANAESTHESIA IN INFRAUMBILLICAL SURGERIES

Dr R Jagadish Raj1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年2月16日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
52
试验地点
1
主要终点
To compare the efficacy of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on motor recovery and post operative ambulation

研究概览

简要总结

Spinal anaesthesia or subarachnoid block is a widely used regional anaesthetic technique in a variety of infraumbillical, perineal and lower limb surgeries. It is achieved by injection of local anaesthetic into subarachnoid space mainly in the lumbar area. 

It results 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 S enantiomer. The S enantiomers are less neurotoxic and cardiotoxic compared to R enantiomers and racemic mixture forms of amide pipecoloxylidide local anaesthetics. Bupivacaine is considered the gold standard long acting local anaesthetic for most regional anaesthetic procedures such as subarachnoid block.

Ropivacaine compared to bupivacaine has a better safety profile but produces a lower grade of motor block and has a shorter duration of action.Studies have been done comparing the clinical effectiveness of 0.75% plain ropivacaine with 0.5% heavy bupivacaine which showed a similar quality of block with late onset and shorter duration of sensory and motor blockade in 0.75% plain ropivacaine. This study aims to compare the efficacy of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on motor recovery and post operative ambulation

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patient willing to give informed consent
  • ASA grade 1 and 2
  • Patients undergoing infraumbilical surgeries under spinal anaesthesia.

排除标准

  • Patients refusing to give informed consent
  • Patients undergoing emergency surgeries
  • Patients with history of allergy to the study drugs
  • Pregnant women
  • Patients ASA grade 3,4,5
  • Patients under 18 years and over 60 years of age.
  • Infection at the site of injection
  • Spinal deformities
  • Severe hypovolemia
  • Coagulopathies
  • Raised intracranial tension.

结局指标

主要结局

To compare the efficacy of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on motor recovery and post operative ambulation

时间窗: baseline, 1, 2, 3, 4, 5, 6, 7. 8, 9, 10 mins, 20, 30, 40, 50, 60, 70, 80, 90 minutes. every 30 minutes till patient able to ambulate

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.(aseline, every minute upto 10 minutes, every 10 minutes upto end of surgery)

研究者

发起方
Dr R Jagadish Raj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr R Jagadish Raj

Bangalore Medical College and Research Institute

研究点 (1)

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