A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Postoperative pain
研究概览
简要总结
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.
详细描述
Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo.
In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery.
The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated.
The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and Males 18-80 years old
- •ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
- •ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
- •ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
- •Patients scheduled for oncological laparoscopic colectomy
- •Patients who do not use opioids analgesic drugs before surgery
- •Patients without cognitive impairment or mental retardation
排除标准
- •Females and Males under 18 or over 80
- •ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
- •ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
- •Emergency/urgency surgery
- •Postoperative admission in an intensive care unit with sedation or ventilatory assistance
- •Cognitive impairment or mental retardation
- •Use of opiods before surgery
- •Progressive degenerative diseases of the CNS
- •Convulsions or chronic therapy with antiepileptic drugs
- •Severe hepatic or renal impairment
- •Allergy to one of the specific drugs under study
- •Acute infection or inflammatory chronic disease
- •Alcohol or drug addiction
- •Any kind of communication problem
- •Neurologic or psychiatric disease
研究组 & 干预措施
Ropivacaine 150 mg
Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system
干预措施: Ropivacaine 150 mg (Drug)
Saline 15 ml
Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system
干预措施: saline 15 ml (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 72 hours
Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU.
次要结局
- Time of unassisted walking(72 hours)
- Return to active bowel function(72 hours)
- Hospital morbidity(72 hours)
- Time and condition for hospital discharge(72 hours)
- Analgesic consumption(72 hours)
研究者
Pablo Mauricio Ingelmo M.D.
Consultant Anesthesiologys. First Service of Anesthesia and Intensive Care
San Gerardo Hospital