Comparison of efficacy and safety of magnesium sulphate and dexmedetomidine in ultrasound guided transversus abdominus plane (TAP) block for postoperative analgesia after Caesarean section:A randomised ,double blind ,non inferiority study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery
研究概览
简要总结
This study is a randomized, double blind, parallel group, comparing
the efficacy and safety of adding Magnesium sulphate or Dexmedetomidine with Bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Cesarean delivery in 90 patients admitted at AIIMS Gorakhpur for elective or emergency Cesarean delivery . The primary outcome measures will be to assess non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery. Secondary
outcomes are to compare mean or median postoperative pain scores at rest and on coughing during first 24 hours ,total mean opioid consumption in first 24 hours, haemodynamic parameters and Satisfaction score in both study groups .Safety outcome will be Recording and reporting of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •35 years females belonging to the American Society of Anesthesiologists (ASA) Class I/II 2 Elective or Emergency LSCS under Subarachnoid block. 3 Normal bleeding profile. 4 No history of relevant drug allergy. 5 Patients willing to participate in the study.
排除标准
- •1 Age <18 and >35 years.
- •2 Patient refusal.
- •3 Significant cardiovascular disease, hepatic dysfunction or renal dysfunction 4 Coagulation abnormalities and Bleeding disorder 5 Infection in the intended intervention site 6 Patient on intravenous MgSO4 7 Eclamptic or preeclamptic patient.
结局指标
主要结局
To assess non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery
时间窗: 0-24 hours post operative period
次要结局
- 1 To compare mean or median postoperative pain scores at rest and on coughing during first 24 hours((immediately after block, 30 min, 1 h, 2h, 4h, 8h, 12h and 24 h) following Caesarean delivery in both study groups)