Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- NRS Pain Scores for the First 12 Hours
研究概览
简要总结
To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.
详细描述
Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of thyroid neoplasm or benign goiter
- •Scheduled for BABA endoscopic or robotic thyroidectomy
排除标准
- •Completion thyroidectomy
- •Modified radical neck dissection
- •Allergy history
- •Stroke history
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Coagulopathy
- •Severe cardiovascular disease
- •Severe pulmonary disease
- •Chronic kidney disease
研究组 & 干预措施
Placebo
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
干预措施: Placebo (Other)
Ropivacaine with epinephrine injection
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
干预措施: Ropivacaine with epinephrine injection (Drug)
结局指标
主要结局
NRS Pain Scores for the First 12 Hours
时间窗: Postoperative 12 hours
The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \~ 10(maximum pain, worse outcome) Unlike the general NRS pain score as reported in the "post-operative 48 hour" result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place.
次要结局
- Maximum of Measured Systolic Blood Pressures(participants were followed for the duration of the operation, an average of approximately 2.5 hours)
- Maximum of Measured Diastolic Blood Pressures(participants were followed for the duration of the operation, an average of approximately 2.5 hours)
- Maximum of Measured Heart Rates(participants were followed for the duration of the operation, an average of approximately 2.5 hours)
- Operation Time(participants were followed for the duration of the operation, an average of approximately 2.5 hours)
- NRS Change(0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation)
- Blood Loss Amount(participants were followed for the duration of the operation, an average of approximately 2.5 hours)
- Pain Killer Dose(0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation)
研究者
Kyu Eun Lee
Associate Professor
Seoul National University Hospital