Comparative study between hyperbaric Levobupivacaine and hyperbaric Bupivacaine in saddle block for anal and perianal surgeries: A prospective, randomised double blind study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1.To compare time for ready to home discharge criteria.
研究概览
简要总结
A prospective , randomized , double blinded comparative study between 0.5% hyperbaric bupivacaine and 0.5% hyperbaric levobupivacaine in saddle type of subarachnoid block for anal and perianal surgeries.
Our objective is to compare the first time to micturition , time to unassisted ambulation , hospital discharge rates.
This is a hospital based, prospective , randomized , double blind study on cohort of patients posted for elective anal and peri anal surgeries under saddle type of subarachnoid block in general surgery elective operating room of Bankura Sammilani Medical College over the period of 18 months.
We are expecting that 0.5% hyperbaric levobupivacaine , in comparison to 0.5% hyperbaric bupivacaine , provides earlier first time to micturition, decreases the time to unassisted ambulation and overall decreases the duration of stay of hospital time.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society of Anaesthesiology I and II 2.Patients undergoing short duration Anal and Perianal Surgeries.
排除标准
- •1.Patient refusal.
- •2.Deformities of vertebral column.
- •3.Neurological diseases.
- •4.Coagulopathy.
- •5.Valvular heart disease.
- •6.Medically not fit for subarachnoid block anaesthesia due to other causes.
- •7.Allergy to study drugs.
结局指标
主要结局
1.To compare time for ready to home discharge criteria.
时间窗: 1.Within 6 hours | 2.Within 5 hours
2.To compare first micturition or voiding time.
时间窗: 1.Within 6 hours | 2.Within 5 hours
次要结局
- 1.To compare between onset and duration of sensory and motor blockade as well as analgesic effect , regression of block, time of first analgesia requirement .(2.To compare adverse effects like nausea, vomiting, PDPH and TNS , Cauda Equina Syndrome.)
研究者
DR SHIVAMBRATA CHAUDHURI
BANKURA SAMMILANI MEDICAL COLLEGE