To evaluate the postoperative analgesia of isobaric levobupivacaine alone compared with clonidine or nalbuphine under spinal anesthesia in patients of lower limb surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the duration of postoperative analgesia of isobaric levobupivacaine alone compared with clonidine or nalbuphine under spinal anesthesia in patients of lower limb surgeries.
研究概览
简要总结
Hyperbaric bupivacaine 0.5% iscommonlyused in spinal anesthesia. Hyperbaric solutions may cause sudden cardiac arrestdue to hypotension, bradycardia because of higher extend of sympatheticblockade. The use of isobaric solutions may decrease these risks. Levobupivacaineis preferred during spinal anesthesia due to its lower cardiovascularside-effects and central nervous system toxicity. Intrathecal adjuvants arecommonly used to improve the quality of intraoperative analgesia and extend itin the postoperative period without significant motor or autonomic blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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.Patients undergoing lower limb surgeries
- •American Society of Anesthesiology (ASA) Grade I and II.
排除标准
- •1.Neurological and musculoskeletal disease.
- •2.Patients with cardiovascular diseases.
- •3.Contraindications to regional anesthesia such as local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
- •4.Hypersensitivity to study drugs 5.Pregnant women 6.History of opioid dependence.
结局指标
主要结局
To evaluate the duration of postoperative analgesia of isobaric levobupivacaine alone compared with clonidine or nalbuphine under spinal anesthesia in patients of lower limb surgeries.
时间窗: pain will be assessed from 0 min till the 24 hours of the surgery
次要结局
- to evaluate the sedative and adverse effects of all the three drugs in the lower limb surgeries(effects will be assessed from 0 min till the 24 hours of the surgery)