CTRI/2024/05/066721尚未招募4 期
Comparison of intraperitoneal nebulization of ropivacaine with ropivacaine-dexmedetomidine for pain management after laparoscopic cholecystectomy: A randomized double blind, placebo-controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To record the time of requirement of first rescue analgesic.
研究概览
简要总结
Laparoscopic cholecystectomy is the treatment of choice in case of cholelithiasis. Intraperitoneal nebulization with ropivacaine with dexmedetomidine intends to provide better control of pain post 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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) The patient giving written and informed consent for study.
- •c) Patients with ASA grade I and II.
- •d) Male and female patients aged between 18-70 years.
排除标准
- •Patients having a clinical diagnosis of acute pancreatitis.
- •Patients having acute preoperative pain other than biliary colic.
- •Patients undergoing chronic pain treatment or on anti-epileptic.
- •Patients with severe renal or hepatic impairment.
- •Patients with history of alcohol or drug addiction.
- •Patients having allergy to the study drugs.
- •Patients with cognitive impairment or communication problems.
- •Pregnant or lactating patients.
结局指标
主要结局
To record the time of requirement of first rescue analgesic.
时间窗: Visual Analogue Scale Score | 3hours post-surgery | 6hours post-surgery | 12hours post-surgery | 24hours post-surgery
次要结局
- a) To record the hemodynamic parameters- systolic blood pressure, diastolic blood pressure, heart rate and MAP every after intraperitoneal nebulization till the end of surgery.
研究者
Dr Karuna Mayee
RAJENDRA INSTITUTE OF MEDICAL SCIENCES
研究点 (1)
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