Anestesia Generale + TAP Block vs Anestesia Generale + CWI Per Intervento di Isterectomia Totale Laparotomica. Trial Randomizzato Controllato.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
This no-profit, monocentric, prospective randomized controlled trial, aims to demonstrate the non-inferiority of continuous wound infusion (CWI) when compared to transversus abdominis plane (TAP) block for postoperative pain control after total abdominal hysterectomy.
详细描述
After signing the informed consent, patients will be enrolled and randomly allocated into either the study group (CWI) or the control group (TAP). Both groups will receive standard general anesthesia. At the end of the surgery, the CWI patients will receive a preperitoneal catheter in the surgical wound and CWI of ropivacaine 2 mg/ml, 5 ml/h for 24 hours; with the TAP block patients will receive a bilateral, standard lateral TAP block with 5 mg/ml ropivacaine 24 ml per side. All patients will receive multimodal analgesia with ketorolac 30 mg e.v. plus 90 mg/24h IV, paracetamol 1g plus 1g TID, dexamethasone 0,1 mg/kg IV preoperatively, oxycodone 5 mg per OS upon request.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I - III
- •laparotomic hysterectomy with Pfannenstiel incision
- •signed informed consent
排除标准
- •allergy to local anesthetics or other components of multimodal analgesia
- •inability to walk or eat
研究组 & 干预措施
group TAP block
TAP block is administered at the end of the surgery, bilaterally, with lateral approach, with 24 ml of 0,5% ropivacaine for each side
干预措施: TAP block (Procedure)
group CWI
A 15 cm long, multihole catheter is placed on the preperitoneal plane before fascia closure; a starting bolus of 10 ml of 0,5% ropivacaine is administered through the catheter, then a continuous infusion of 0,2% ropivacaine at a rate of 5 ml/h is started through a pump and continued for 48 hours
干预措施: Continuous Wound Infusion (Procedure)
结局指标
主要结局
opioid consumption
时间窗: Change from baseline and hours 6, 12, 24, 48
morphine equivalents requested (patients request oxycodone 5 mg (7,5 mg morphine equivalents) each time they experience pain at intensity higher than 4 in the NRS scale
次要结局
- postoperative pain at rest(hours 6, 12, 24, 48)
- postoperative pain during movements(hours 6, 12, 24, 48)
- early mobilization SIT-STAND-WALK(hours 3, 12, 24, 48)
- vital parameters stability YES/NO(hours 3, 12, 24, 48)
- vital parameter ( heart rate) stability YES/NO(hours 3, 12, 24, 48)
- vital parameter (oxygen saturation) stability YES/NO(hours 3, 12, 24, 48)
- complications(hours 0, 6, 12, 24, 48 (days 30 for DVT))
- Costs of all procedure(hour 0)
- Postoperative Nausea and Vomiting (PONV)(hours 6, 12, 24, 48)
- Home dischargeable YES/NO(hours 3, 12, 24, 48)
- HCP time consuming(hour 0)
- early refeeding(hours 3, 12, 24, 48)
研究者
Fabio Costa
Consultant Department of Anesthesia - Principal Investigator
Campus Bio-Medico University