Comparative study of Dexamethasone and Midazolam as adjuvants to Ropivacaine in Transversus abdominis plane block on post operative analgesia after Laparoscopic lower abdominal surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Time duration when first rescue analgesia was needed
研究概览
简要总结
A double-blind prospective randomised comparative study will be conducted on 60 patients scheduled for laparoscopic lower abdominal surgeries. Patients will be randomly allocated using computer generated random number to be treated with either dexamethasone (Group D) or preservative free midazolam (Group M). After completion of surgery ultrasound guided TAP block will be performed in patients of both the groups. Patients in Group D will receive 0.2% ropivacaine (20 ml) and 2ml normal saline containing 4mg dexamethasone whereas patients in Group M will receive 0.2% ropivacaine (20 ml) and 2ml normal saline containing 2 mg of preservative free midazolam. Patients will be shifted to post anaesthesia care unit (PACU) where post-op monitoring of pain (by VAS score), sedation (by Ramsay sedation scale), postoperative nausea and/or vomiting (0: no nausea; 1: nausea no vomiting; and 2: nausea and vomiting), and complications (like pruritus, headache, local anaesthetic systemic toxicity) will be done till 24h after surgery
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
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing Laparoscopic lower abdominal surgeries.
- •ASA 1 or 2 physical status.
排除标准
- •Refusal of consent.
- •Local site infection.
- •Any contraindication to peripheral nerve block.
- •Morbid obese (BMI more than or equal to 40kg/m2)
- •Dropout ( Laparoscopic surgeries converted into open surgeries).
结局指标
主要结局
1. Time duration when first rescue analgesia was needed
时间窗: Immediately after shifting to post-op, 1 Hour, 2 Hour, 4 Hour, 6 Hour, 8 Hour, 12 Hour, 16 Hour, 20 Hour, 24 Hour
2. Total dose of rescue analgesia
时间窗: Immediately after shifting to post-op, 1 Hour, 2 Hour, 4 Hour, 6 Hour, 8 Hour, 12 Hour, 16 Hour, 20 Hour, 24 Hour
次要结局
- To study hemodynamic variability, post-op nausea and vomiting and sedation.(within 24 hours post operatively.)
研究者
vaibhav kumar
Institute of Medical Sciences, BHU