Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Preoperative and Postoperative Nebulization of Ropivacaine on 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
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.
详细描述
Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.
The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
Preoperative Nebulization
Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery
干预措施: Ropivacaine 30 mg (Drug)
Postoperative Nebulization
Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery
干预措施: Ropivacaine 30 mg (Drug)
Control
Nebulization of normal saline 3 ml before and after surgery
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 48 hours
Postoperative pain will be assessed by numeric ranking scale (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
- Time of unassisted walking(Up to 48 hours)
- Morphine consumption (mg)(Up to 48 hours)
- Hospital morbidity(Up to 48 hours)
- Time to hospital discharge(48 hours)
