CTRI/2025/05/086968尚未招募4 期
A Comparative evaluation of hyperbaric levobupivacaine versus hyperbaric bupivacaine for elective infra umbilical surgeries under spinal anaesthesia.A randomized trial.
Dr Suhas Kumar Mall1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月2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
- 60
- 试验地点
- 1
- 主要终点
- To determine the time to onset of sensory block,
研究概览
简要总结
| Spinal anaesthesia is an easy inexpensive and preferable technique for elective below umbilical surgeries. This study will compare the clinical effect, safety, and postoperative recovery profile of hyperbaric levobupivacaine and hyperbaric ropivacaine for elective below umbilical surgeries under Spinal anaesthesia. We will determine the time to onset of sensory block, time to peak sensory block, duration of sensory block, time to complete the motor block, duration of the motor block, duration of analgesia, intraoperative hemodynamic, postoperative recovery profile and Complications (If Any ). It’s a Prospective, randomized and comparative study of duration of 2 years, conducted at patients coming to All India Institute of Medical Sciences, Gorakhpur, which falls in the inclusion criteria. All samples collected during the above-mentioned period will be included in this study. Minimum of 60 patients; 30 in each group. Patients will be divided into: **GROUP L:**Patients in this group received intrathecal 15 mg (3 ml) of 0.5% hyperbaric Levobupivacaine. **GROUP B:**Patients in this group received intrathecal 15 mg (3 ml) of 0.5% hyperbaric Bupivacaine. Patients will be given drugs as per the opening of the envelope and after following the standard protocol of consent, attaching a multipara monitor and aseptic measure, spinal is given. The objectives will be measured at a specific time duration and patient data will be documented in the specified group. The data will be compared and the conclusion and discussion will be made as per the available results. |
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
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients of the American Society of Anesthesiologists I, II, and III.
- •b) Weight 40-80 kg c) Elective infra-umbilical surgeries of approximately 2 ½ hrs.
- •d) Patients who have given informed written consent.
排除标准
- •a) Patient refusal.
- •b) Infection.
- •c) Coagulopathy.
- •e) Spinal deformity.
- •f) Patients of American Society of Anesthesiologists IV.
- •g) Allergic to local anesthetic drugs.
- •h) H/O seizures and neurological deficit.
- •i) Severe renal, hepatic, respiratory and cardiovascular disease.
- •j) Lack of informed written consent.
结局指标
主要结局
To determine the time to onset of sensory block,
时间窗: Time to onset of sensory and motor block after | giving drug. Time of duration of sensory and | motor block till the next 24 hours and | intraoperative hemodynamic monitoring every | 1,3,5,10,15 mins and then every 15mins for the | next 2 hours.
time to peak sensory block and duration of
时间窗: Time to onset of sensory and motor block after | giving drug. Time of duration of sensory and | motor block till the next 24 hours and | intraoperative hemodynamic monitoring every | 1,3,5,10,15 mins and then every 15mins for the | next 2 hours.
sensory block.
时间窗: Time to onset of sensory and motor block after | giving drug. Time of duration of sensory and | motor block till the next 24 hours and | intraoperative hemodynamic monitoring every | 1,3,5,10,15 mins and then every 15mins for the | next 2 hours.
次要结局
- (a) To determine the time to onset of sensory(block, time to peak sensory block & duration of)
研究者
Dr Suhas Kumar Mall
All India Institute of Medical Sciences. Gorakhpur.
研究点 (1)
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