To evaluate the efficacy of epidural analgesia with Ropivacaine 0.2% and levobupivacaine 0.25% in lower limb orthopaedic surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in the pain by epidural analgesia in lower limb orthopedic surgeries.
研究概览
简要总结
post operative pain is troublesome after orthopedic surgeries, effective pain relief causes early and smooth recovery. to provide effective analgesia we intend to compare 0.2% ropivacaine and 0.25% levobupivacaine. via epidural route.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •ASA physical status 1 and 2
- •Written and informed consent given by patient.
- •Patient scheduled for eledtive lower limb orthopedic surgeries under combined spinal epidural anesthesia.
排除标准
- •1.Refusal for participation.
- •2.Known allergy or contraindication to the drugs used.
- •3.Cerebrovascular disease.
- •4.Intracranial hypertension.
结局指标
主要结局
Reduction in the pain by epidural analgesia in lower limb orthopedic surgeries.
时间窗: T0: First test dose intraoperatively | T60: 60 min after test dose | T150: 150 min after test does | T1: 1 hour postoperatively | T2: 2 hours postoperatively | T4: 4 hours postoperatively | T8: 8 hours postoperatively | T12: 12 hours postoperatively | T16: 16 hours postoperatively | T24: 24 hours postoperatively | T36: 36 hour postoperatively | T48: 48 hour postoperatively
次要结局
- 1.Lower incidence of hypotension and bradycardia(2.Incidence of PONV)
研究者
Dr. Samruddhi Dhamdhere
Smt Kashibai Navale Medical College and General Hospital, Pune