Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
研究概览
简要总结
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesia physical status class I & II
- •Age ≥ 20 and ≤ 65 years
- •Robot- assisted endoscopic thyroidectomy
排除标准
- •Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
- •Body mass index ≥ 40 kg/m2
- •History of seizure disorder
- •Current therapy with pregabalin, gabapentin, or any opioid
- •Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
- •Insulin-dependent diabetes mellitus
- •Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)
研究组 & 干预措施
Placebo
Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later
干预措施: Vitamin Complex (placebo) (Drug)
Pregabalin
Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
干预措施: Pregabalin (Drug)
结局指标
主要结局
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
时间窗: 1, 6, 24 & 48 hours
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
时间窗: 1, 6, 24 & 48 hours
Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision.
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
时间窗: 1, 6, 24 & 48 hours
次要结局
- Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.(3 months)