Comparision of intrathecal morphine in two different doses as an adjuvant to hyperbaric ropivacaine versus plain hyperbaric ropivacaine in lower limb orthopedic surgeries double blind randomized controlled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Primary outcome will be to evaluate the need for first analgesic dose.
研究概览
简要总结
Post operative pain after major orthopedic surgeries can be controlled by intrathecal administration of opioids and local anaesthetics. Effective intrathecal analgesia achieved through synergism between local anaesthetics and opioids is a well established phenomenon1. In some of the studies, it is stated that addition of opioids like morphine or fentanyl to local anaesthetic like bupivacaine or ropivacaine may improve the quality of analgesia. As ropivacaine poses the natural vasopressor property, it might contribute to prolongation of analgesia by reducing its local clearance4. This is a double blind randomized controlled study in which 114 patients of ASA I and II patient, of either sex, aged between 18-65 years, with lower limb surgeries requiring sub-arachanoid block will be randomized into three groups of 38 each. Group R will receive hyperbaric 0.75% ropivacaine, Group RM1will receive hyperbaric 0.75% ropivacaine with 100 mcgm morphine and Group RM2 will receive hyperbaric 0.75% ropivacaine with 200 mcgm morphine. The primary objective is to determine the analgesia duration and secondary objective is to determine the efficacy of respective drugs in terms of onset and duration of sensory and motor blockade along with two dermatomal segment regression,and any side effect in each group
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
- •American society of Anaesthesiologists (ASA) grade I/II patients undergoing lower limb orthopedic surgical procedures under spinal anaesthesia. Age group:
- •65 years of any sex. Patient voluntary participate in the study.
排除标准
- •Contraindication to spinal anaesthesia.
- •History of allergy to morphine or ropivacaine.
- •Patients with severe psychiatric disorder such as depression, dementia or drugs which could interfere with the comprehension of the study.
- •Patients with history of any cardiac disease, coagulopathy or any respiratory disorder.
结局指标
主要结局
Primary outcome will be to evaluate the need for first analgesic dose.
时间窗: Post operatively after 2 hours.
次要结局
- the secondary outcome will be to assess the onset and duration of sensory and motor blockade along with hemodynamic parameters and side effects(Immediately after spinal anaesthesia)