Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after gynecologic laparoscopic surgery.
详细描述
Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic surgery have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. The investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief than ropivacaine instillation after gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization before or after surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic laparoscopic procedures.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females 18-70 years old, ASA score 1 - 3;
- •scheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;
- •free from pain in preoperative period, without habitual analgesic use;
- •without cognitive impairment or mental retardation, who gave a written informed consent
排除标准
- •Females under 18 or over 70;
- •ASA 4 or 5;
- •emergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;
- •habitual analgesic use; progressive degenerative diseases of the CNS;
- •convulsions or chronic therapy with antiepileptic drugs;
- •severe hepatic or renal impairment;
- •pregnancy or lactation;
- •allergy to one of the specific substances used in the study;
- •acute infectious disease or inflammatory chronic disease, alcohol or drug addiction;
- •any kind of communication problem;
- •neurologic or psychiatric disease;
- •no written informed consent
研究组 & 干预措施
CONTROL group
干预措施: saline (Drug)
PREOPERATIVE nebulization
干预措施: Ropivacaine 30 mg (Drug)
POSTOPERATIVE nebulization
干预措施: Ropivacaine 30 mg (Drug)
INSTILLATION group
干预措施: Ropivacaine 100 mg (Drug)
结局指标
主要结局
postoperative pain
时间窗: 24 hours
Postoperative pain was assessed by NRS (0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS \< 3) will also be assessed.
次要结局
- morphine consumption(24 hours)
- Unassisted walking time(24 hours)
- Hospital stay(between surgery and discharge)
- hospital morbidity(up to discharge)
研究者
Pablo Mauricio Ingelmo M.D.
MD
San Gerardo Hospital