Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acute postoperative pain
研究概览
简要总结
For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI < 30 kg/m2
- •Scheduled for laparoscopic cholecystectomy
- •ASA grade I, II and III
排除标准
- •Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis
- •Conversion to open cholecystectomy or if the surgery exceeded 200 minutes
- •Severe systemic disease
- •Patients on analgesics for any reason
- •History of allergy to local anesthetics
- •An ongoing pregnancy
- •Patient refusal
结局指标
主要结局
Acute postoperative pain
时间窗: up to 24 hours
Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough
Total opioid consumption
时间窗: Day 1
次要结局
- Length of hospital stay(up to 1 week)
- postoperative nausea and vomiting(Day 1)
- Patient satisfaction and quality of recovery(Day 1)
- Incidence of shoulder pain(Day 1)
- Postoperative complication(up to 1 week)
研究者
Daghmouri Mohamed Aziz
Principal investigator
Tunis University