Comparison of efficacy of plain bupivacaine versus bupivacaine with dexmedetomidine versus bupivacaine with clonidine in Ultrasound Guided transversus abdominis Plane Block for duration of postoperative analgesia in patients undergoing lower abdominal surgeries A double blind randomized controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Primary objective: Comparison of efficacy of plain Bupivacaine versus Bupivacaine
研究概览
简要总结
This study evaluates the efficacy of Transversus Abdominis Plane (TAP) block with different adjuvants for postoperative pain relief in lower abdominal surgeries.
• Participants: Patients undergoing surgery, recruited after consent.
• Randomization: Patients are divided into 3 groups (36 each):
• Group B: 0.25% bupivacaine (20 ml/side).
• Group BC: 0.25% bupivacaine + clonidine (1 µg/kg, 20 ml/side).
• Group BD: 0.25% bupivacaine + dexmedetomidine (0.5 µg/kg, 20 ml/side).
• Procedure: TAP block performed under ultrasound guidance. Vitals, pain (NRS), and sedation (Ramsay score) monitored at intervals for 24 hours. Rescue analgesics (paracetamol or diclofenac) will be administered as needed.
• Outcomes:
• Primary: Duration of analgesia (time to significant pain).
• Secondary: Rescue analgesic consumption and side effects.
• Sample Size: 108 patients (36 per group) based on prior studies and statistical power.
This study compares bupivacaine alone and in combination with clonidine or dexmedetomidine for prolonged and effective pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA Grade I or II.
- •2.Patients undergoing lower abdominal surgeries.
- •3.Patients undergoing surgery under spinal.
排除标准
- 未提供
结局指标
主要结局
Primary objective: Comparison of efficacy of plain Bupivacaine versus Bupivacaine
时间窗: Before giving block and after giving block 0 hour, 2hour, 4th hour, 6th hour | 8 th hour, 12 th hour,16 th hour, 20th hour and 24 th hour
with Dexmedetomidine versus Bupivacaine with Clonidine in Ultrasound Guided
时间窗: Before giving block and after giving block 0 hour, 2hour, 4th hour, 6th hour | 8 th hour, 12 th hour,16 th hour, 20th hour and 24 th hour
Transversus Abdominis Plane Block for duration of postoperative analgesia in patients
时间窗: Before giving block and after giving block 0 hour, 2hour, 4th hour, 6th hour | 8 th hour, 12 th hour,16 th hour, 20th hour and 24 th hour
undergoing lower abdominal surgeries.
时间窗: Before giving block and after giving block 0 hour, 2hour, 4th hour, 6th hour | 8 th hour, 12 th hour,16 th hour, 20th hour and 24 th hour
次要结局
- 1. Side effects of the administered drugs.(2. Sedation (using modified Ramsay sedation score))
研究者
Raghulpandi
AIIMS RAIPUR