Comparison of two different doses of Nalbuphine as an adjuvant to 0.75% Hyperbaric Ropivacaine for postoperative analgesia in parturients undergoing lower segment caesarean section under subarachnoid block. A randomized double-blinded controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
研究概览
简要总结
This randomized double-blinded controlled study aims to compare the analgesic efficacy of two different doses of intrathecal Nalbuphine (0.4 mg and 0.8 mg) used as an adjuvant to 0.75% hyperbaric Ropivacaine in parturients undergoing elective lower segment caesarean section under subarachnoid block. A total of 105 parturients will be randomly allocated into three groups to receive either hyperbaric Ropivacaine alone or in combination with Nalbuphine. The primary outcome is the duration of postoperative analgesia, while secondary outcomes include sensory and motor block characteristics, postoperative pain scores, haemodynamic stability, neonatal outcome assessed by APGAR scores, and the incidence of adverse effects. The study intends to identify the optimal dose of intrathecal Nalbuphine that provides effective and prolonged analgesia with minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Term parturients aged 18–35 years with ASA physical status II, scheduled for elective uncomplicated lower segment caesarean section under subarachnoid block, and willing to provide written informed consent will be included in the study.
排除标准
- •Parturients refusing to participate, those with ASA physical status III or above, body mass index more than 35 kg/m², known hypersensitivity to local anaesthetics or Nalbuphine, presence of cardiac, renal or hepatic disease, pre-existing neurological disorders or peripheral neuropathy, those on anticoagulant therapy or having coagulation abnormalities, infection at the site of lumbar puncture, or any contraindication to subarachnoid block will be excluded from the study.
研究者
Dr Kamini Kumari
R.N.T Medical College