Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Postoperative Pain (Pain Scores) Intensity Measure
研究概览
简要总结
The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.
详细描述
The investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. All patients ASA physical status I-II grade, aged within 20-70 years, are randomly allocated into two groups: 75mg/20ml ropivacaine only group (Group R, n=30) and 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine (Group RD, n=30). At the end of surgery, the investigators perform four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side where 5ml solution is injected to each point. The characteristics of patients are analyzed to confirm whether they are comparable in both groups. Pain was assessed according to a numerical rating scale (NRS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded in post anesthesia care unit(PACU), and1, 2,4, 8, 12, 24, 36 and 48 hours after surgery. The study endpoints are evaluated by an anesthesiologist who does not know the group allocation. The postoperative rescue analgesic administration, adverse outcomes and patient satisfaction are also recorded.
All data were processed in SPSS 18.0 (SPSS Inc., Chicago, IL USA). Normality was tested by the Kolmogorov-Smirnov analysis. Comparisons of continuous outcomes among groups were examined using Kruskal-Wallis test. Chi-square analysis or Fisher's exact test was used to assess categorical outcomes between groups. A P-value<0.05 was considered statistically significant.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II grade
- •Undergoing elective video-assisted pneumonectomy under general anesthesia.
- •Participants aged from 30-70 years old.
排除标准
- •Refusal for paravertebral block
- •Inability to obtain informed consent
- •Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
- •Pregnancy
- •Infections at the site of injection for the paravertebral block
- •Allergy to local anesthetics or alpha-2 adrenergic agonists
- •Heart block or bradycardia (heart rate < 60 beat per minute)
- •Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
结局指标
主要结局
Postoperative Pain (Pain Scores) Intensity Measure
时间窗: assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
Pain Numerical Rating Scales (NRS) at rest(0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
次要结局
- Patient Satisfaction(Hour 48 after surgery)
- Number of Participants With Postoperative Rescue Analgesic Administration(Hour 24, Hour 48 after surgery)
- Adverse Events(Hour 48 after surgery)
研究者
Jianghui Xu
MD
Huashan Hospital
