Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 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 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.
详细描述
In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or after gynaecologic laparoscopic surgery significantly reduces postoperative pain and postoperative morphine consumption.
Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®).
However, almost all patients still use morphine after surgery.
The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine after the laparoscopic ovarian cyst surgery.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 18-65 years old
- •ASA Score I-III
- •Scheduled for ovarian cyst laparoscopic surgery
- •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 instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery
干预措施: Ropivacaine instillation (Drug)
Ropivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
干预措施: Ropivacaine nebulization (Drug)
结局指标
主要结局
Morphine consumption (mg)
时间窗: Up to 24 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
- Postoperative Pain(Up to 24 hours)
- Time of unassisted walking(Up to 24 hours)
- Hospital morbidity(Up to 24 hours)
- Hospital stay(Up to 24 hours)
- Quality of life after surgery(Four weeks after surgery)
研究者
Pablo Mauricio Ingelmo M.D.
Consultant Anesthesiologyst
San Gerardo Hospital