CTRI/2024/03/064211
尚未招募
2 期
A comparison of efficacy of 0.0625% Levobupivacaine with Fentanyl and 0.1% Ropivacaine with Fentanyl for postoperative analgesia after CRS+HIPEC-A pilot study
Rajiv Gandhi Cancer Institute and Research Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月26日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Rajiv Gandhi Cancer Institute and Research Center
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- compare VAS pain score to assess postoperative analgesia between two study groups
概览
简要总结
this is the study to compare the analgesic effectiveness and hemodynamic changes of continuous epidural infusion of 0.0625% Levobupivacaine with Fentanyl and 0.1% Ropivacaine with Fentanyl for postoperative analgesia after CRS+HIPEC. In both groups drugs will be infused @ 6ml/hr. Rescue analgesia will be provided with intravenous Injection tramadol 50 mg SOS.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •patient undergoing CRS with HIPEC for solid organ GI and Ovarian malignancy with peritoneal metastasis.
排除标准
- •Patient refusal or contraindication for epidural catheter.
- •ASA physical status 3 and more.
结局指标
主要结局
compare VAS pain score to assess postoperative analgesia between two study groups
时间窗: Every 6 hourly on postoperative day then every 12 hourly for next 3-4 days till epidural catheter is in situ
次要结局
- Requirement of rescue analgesia doses and total volume of drug used for epidural infusion(Every 6 hourly on postoperative day then every 12 hourly for next 3-4 days till epidural catheter is in situ)
研究者
Dr Vishal Bhatnagar
Rajiv Gandhi Cancer Institute & Research Centre New Delhi
研究点 (1)
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