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临床试验/CTRI/2024/01/061783
CTRI/2024/01/061783尚未招募Phase 3 4

COMPARATIVE STUDY OF HYPERBARIC LEVOBUPIVACAINE O.5% AND HYPERBARIC ROPIVACAINE 0.75 % IN SPINAL ANAESTHESIA IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES

Jawaharlal Nehru Medical College and Hospitals1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月31日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Duration of Analgesia

研究概览

简要总结

This will be a hospital based prospective, randomised, double blind study conducted to compare the duration of analgesia, onset and duration of sensory and motor block and side effects of Hyperbaric Levobupivacaine 0.5% and hyperbaric ropivacaine 0.75% in patients undergoing Lowerlimb orthopaedic surgery. For this study Adult population between 20 years to 60 years of age group with ASA grade 1 and 2 with exemption of all exclusion criteria mentioned above and undergoing Lowerlimb orthopaedic surgery. Primary objective of the study is to assess the duration of analgesia. The secondary objective of the study is to assess the onset and duration of sensory block, onset and duration of motor block, haemodynamic parameters and its side effects. Participants are allocated into two different groups, each with 50 number sample size. Group R will receive 0.75% Hyperbaric ropivacaine 3ml intrathecally and group L will receive 0.5% Hyperbaric Levobupivacaine 3ml intrathecally.Preanaesthetic evaluation will be done on the day before surgery. Informed written consent obtained before procedure.Patients will be monitored intra operatively and post operatively upto 24 hours at pre described time intervals and documented. Data will be analysed statistically using standard quantitative and qualitative tests

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective Lowerlimb orthopaedic surgery ASA status 1 and 2.

排除标准

  • Age less than 20 years and age above 60 years ASA status 3 and 4 Any known hypersensitivity or contra indication to bupivacaine or ropivacaine Patients with history of coagulopathy Patients with spine deformity Patients with local skin infection at site of injection Patients who had shivering even before administering spinal anaesthesia.

结局指标

主要结局

Duration of Analgesia

时间窗: Perioperatively,at 5 min, at 10min

次要结局

  • Onset & duration of sensory block(Onset & duration of motor block)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mohammed Han B

Jawaharlal Nehru Medical College and Hospitals , Ajmer , Rajasthan

研究点 (1)

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