Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many chronic rhinosinusitis for whom the medical treatment failed. In order to improve the postoperative management of patients treated with ESS, we aim to assess the analgesic action of local injection of ropivacaine in the nasal fossa.
详细描述
A prospective randomized double blind placebo controlled study was designed. Local injection of ropivacaine or placebo was conducted at the end of the surgical procedure in both nasal fossa through endoscopic view in the sphenopalatine region.
Pain was measured in the postoperative course with visual analogic scale in the recovery room and the rhinologic department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients requiring endoscopic sinus surgery
- •ASA score 1 or 2
- •patients with health care insurance
- •approved consent
排除标准
- •any sinonasal malignant tumor
- •renal failure, hepatic disorder, respiratory deficiency, cardiovascular diseases
- •neurologic disorders
- •alcohol or drugs addiction
- •preoperative facial pain from an extranasal origin
- •coagulation disorders
- •antidepressive treatment
研究组 & 干预措施
saline solution 0.9%
injection of saline solution in the sphenopalatine area in both nasal fossa
干预措施: saline solution 0.9% (Drug)
ropivacaine (2mg/ml)
injection of ropivacaine in the sphenopalatine area in both nasal fossa
干预措施: ropivacaine (Drug)
结局指标
主要结局
Visual analog scale
时间窗: at the 2 postoperative hours
Measure the intensity pain, in the group treated with Ropivacaine.
次要结局
- Analgesics consumption orally(during the 7 days post-surgery)
- Administration of analgesics by parenteral route(at the 2 postoperative hours)
- Visual analog scale for the during postoperative pain(At Morning and evening between the 1 and 7 days post surgery)
- Visual analog scale for the intensity postoperative pain(at the 4 and at the 6 postoperative hours)