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临床试验/NCT02814890
NCT02814890已完成不适用

Thoracic Paravertebral Block Using Ropivacaine With/Without Dexmedetomidine in Video-assisted Pneumonectomy

Jianghui Xu1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年8月最近更新:
适应症

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

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

发起方
Jianghui Xu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jianghui Xu

MD

Huashan Hospital

研究点 (1)

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