Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Morphine consumption (mg)
研究概览
简要总结
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg, 100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic cholecystectomy.
详细描述
Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy has been proved to significantly reduce postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting in comparison with patients receiving direct instillation of Bupivacaine 50 mg or placebo.
Ropivacaine can be effectively administrated with non-heating nebulizers (AeronebPro®). In a recent study our group found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy significantly reduced postoperative pain and morphine consumption. Nonetheless, most patients still need strong opioid based analgesia after surgery.
We hypothesize that intraperitoneal nebulization of Ropivacaine 100 mg and 150 mg (maximum recommended dose in adults 300 mg or up to 3 mg/kg) may prevent the use of morphine during the first day after surgery maintaining ropivacaine plasma levels below toxic concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and Males 18-75 years old
- •ASA Score I-III
- •Scheduled for laparoscopic cholecystectomy
- •Free from pain in preoperative period
- •Not using analgesic drugs before surgery
- •Without cognitive impairment or mental retardation
- •Written informed consent
排除标准
- •Emergency/urgency surgery
- •Postoperative admission in an intensive care unit
- •Cognitive impairment or mental retardation
- •Progressive degenerative diseases of the CNS
- •Seizures or chronic therapy with antiepileptic drugs
- •Severe hepatic or renal impairment
- •Pregnancy or lactation
- •Allergy to one of the specific drugs under study
- •Acute infection or inflammatory chronic disease
- •Alcohol or drug addiction
研究组 & 干预措施
Ropivacaine 50 mg
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
干预措施: Ropivacaine 50 mg (Drug)
Ropivacaine 100 mg
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
干预措施: Ropivacaine 100 mg (Drug)
Ropivacaine 150 mg
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
干预措施: Ropivacaine 150 mg (Drug)
结局指标
主要结局
Morphine consumption (mg)
时间窗: Up to 48 hours
The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display
次要结局
- Time of unassisted walking(Up to 48 hours)
- Hospital morbidity(Up to 48 hours)
- Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine(Up to 360 minutes)
- Ropivacaine pharmacokinetics profile: Tissue drug analysis(Up to 2 hours)
- Postoperative Pain(Up to 48 hours)
- Time and condition for hospital discharge(Up to 48 hours)
- Quality of life after surgery(Four weeks after surgery)