“Clinical evaluation of efficacy and safety of transversus abdominis plane block inj. Bupivacaine vs. inj. Ropivacaine for post operative analgesia following lower segment cesarean section: a prospective, randomized, controlled, double blind study.â€
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 compare efficacy and safety of bupivacaine and ropivacaine for post operative pain relief in lower segment cesarean section with Visual Analogue Score and total dose of rescue analgesia.
研究概览
简要总结
Thisstudy is prospective, randomized, controlled, double blind study parallelgroup, comparing the safety and efficacy of bupivacaine and ropivacaine in transversusabdominis plane block after lower segment cesarean section.
Inthis study bupivaiane will be given in transversus abdominis plane block afterlower segment cesarean section in dose of 0.25% 15 ml bilataerally an in othergroup ropivacainewill be given in dose of 0.25% 15 ml bilataerally
Theprimary outcome is- To compare efficacy and safety of bupivacaine and ropivacaine for post operative pain relief in lowersegment cesarean section with Visual Analogue Score and total dose of rescueanalgesia.
The secondary outcomes are- Effect on hemodynamic variables like Heart Rate(HR), Mean Arterial Pressure (MAP), Oxygen saturation (SpO2).
Sideeffects & Complications if any.
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
- 20.00 Year(s) 至 35.00 Year(s)（—）
入选标准
- •ïƒ˜Informed written consent for participation in study.
- •ïƒ˜Age: 20-35 years Gender: Antenatal female patients scheduled for elective or non urgent lower segment cesarean section.
- •ïƒ˜ASA physical status I and II.
- •ïƒ˜Patients refusing consent.
排除标准
- •1.Contraindications to Spinal Anaesthesia like, Local infection or sepsis at the site of Lumbar puncture Bleeding disorders, thrombocytopenia Space occupying lesions of the brain Anatomical disorders of the spine Hypovolaemia e.g. following massive haemorrhage 2.Allergy to local anaesthetic drugs and NSAIDS.
- •3.Patient on any form of analgesics therapy.
- •4.BMI ≥ 25 kg/m2.
结局指标
主要结局
To compare efficacy and safety of bupivacaine and ropivacaine for post operative pain relief in lower segment cesarean section with Visual Analogue Score and total dose of rescue analgesia.
时间窗: 1st day of lower cesarean section(First 24 hours after lower segment cesarean section)
次要结局
- Effect on hemodynamic variables like Heart Rate (HR), Mean Arterial Pressure (MAP), Oxygen saturation (SpO2).(Side effects & Complications if any.)