Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block in Patients Undergoing Video-assisted Thoracic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change of thoracic paravertebral block analgesia duration
研究概览
简要总结
This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively.
详细描述
The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press.The secondary outcomes were to compare the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h, and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use, phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual analogue scale.
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
- Double (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
- •(1) age 18 to 65 years,
- •(2) scheduled to undergo video-assisted thoracic surgery,
- •(3) American Society of Anesthesiologists risk classification I-II.
排除标准
- •(1) patient refusal;
- •(2) known hypersensitivity to the study medication (ropivacaine);
- •(3) long-term use of opioids;
- •(4) liver or renal insufficiency;
- •(5) a history of psychiatric or neurological disease;
- •(6) deafness;
- •(7) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and
- •(8) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.
研究组 & 干预措施
dexmedetomidine group
thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine 100 ug every time
干预措施: Dexmedetomidine Group (Drug)
dexamethasone Group
thoracic paravertebral blocks using a combination of ropivacaine and dexamethasone 10 mg every time
干预措施: dexamethasone group (Drug)
control group
thoracic paravertebral blocks using only ropivacaine
干预措施: control group (Drug)
结局指标
主要结局
Change of thoracic paravertebral block analgesia duration
时间窗: Change from Baseline to 2 days after surgery
The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press
次要结局
- blood concentrations of ropivacaine(Change from Baseline to 2 days after surgery)
研究者
Wen-fei Tan
Professor
China Medical University, China