CTRI/2025/09/095111尚未招募4 期
Comparison of Equipotent Doses of Hyperbaric Ropivacaine and Bupivacaine in Spinal Anaesthesia to Evaluate Effect on Postoperative Urinary Retention in Patients Undergoing Endovenous Laser Ablation for Varicose Veins: A Randomised Double Blind study
Rabindranath Tagore Medical College1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年10月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time to void urine post spinal block measured in minutes
研究概览
简要总结
Our goal is to compare the clinical effectiveness and safety profile of equipotent doses of available commercial preparations of hyperbaric ropivacaine (0.75 percent) versus hyperbaric bupivacaine (0.5 percent ) using a fixed dose of 2.5ml in two groups for spinal anaesthesia in patients undergoing EVLA to compare effect on post operative urinary retention in terms of time to void urine post spinal block
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Age 18-60 years of both sex American society of Anesthesiologists physical status I-II Height 150-175 centimetres Weight 40-90 kilograms.
排除标准
- •Patient refusal Patient with any contraindication to subarachnoid block like coagulopathies or anticoagulant medication, raised intracranial pressure, local injection site infection, severe stenotic valvular heart disease.
- •Patients having Pregnancy, neurological, psychiatric, renal calculus, prostatic disease, diabetes with autonomic neuropathy, urinary tract disease Patients on beta blockers, alpha 2 agonists and diuretics therapy that may interfere with micturition Any patients with hypertension, cardiac, renal, liver, endocrine, haematological or any coexisting systemic medical comorbidity Obesity (body mass index more than 30kg per meter square ), opioid drug addiction Patients who need to be catheterized preoperatively on table by surgeon in view of any coexisting illness, or risk of postoperative urinary retention History of allergy to study drugs.
结局指标
主要结局
Time to void urine post spinal block measured in minutes
时间窗: Time to void urine post spinal block measured in minutes
次要结局
- Need for urinary catheterisation due to “inability to void urine 8 hours after the surgery despite having distended bladder or earlier if patient being uncomfortable due to POUR ((Complications due to POUR postoperatively such as abdominal pain, nausea. vomiting, hypotension /hypertension, bradycardia /tachycardia, arrhythmia and their treatment)
研究者
Dr Udita Naithani
Rabindranath Tagore Medical College
研究点 (1)
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