Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Post-operative Pain Measured by Visual Analogue Scale
研究概览
简要总结
The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).
The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
- •Informed consent
排除标准
- •Intolerance to used medication
- •Recurrent disease
- •Neck dissection, sternotomy
- •Emergency surgery
研究组 & 干预措施
placebo cervical block after surgery
placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)
干预措施: placebo bilateral superficial cervical block (Drug)
cervical block after surgery
bilateral superficial cervical block, placed after surgery (just after skin closure)
干预措施: bilateral superficial cervical block (Drug)
cervical block before surgery
bilateral superficial cervical block, placed before surgery (just before skin incision)
干预措施: bilateral superficial cervical block (Drug)
placebo cervical block before surgery
placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)
干预措施: placebo bilateral superficial cervical block (Drug)
结局指标
主要结局
Post-operative Pain Measured by Visual Analogue Scale
时间窗: 6 hours after surgery
Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Pooled Relative Treatment Effect of VAS
时间窗: 4 days after surgery
Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain) The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)
次要结局
- Hospital Stay(90 days)
- Consumption of Post-operative Analgetics(5 days after surgery)
- Mean Consumption of Post-operative Analgetics(5 days after surgery)
- Post-operative Pain Measured by Visual Analogue Scale(24 hours after surgery)
研究者
Thomas Steffen
attending surgeon
Cantonal Hospital of St. Gallen