Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Post-operative pain
研究概览
简要总结
The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The statistician will be masked to the groups the participants fall in (case vs control).
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Classification (ASA Class) 3 and below.
- •Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (<200 gm), breast augmentation and breast reduction, etc.
排除标准
- •Patients who refuse local anesthesia.
- •Patients who cannot receive local anesthesia.
- •Below the age of 20 and above the age of
- •Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
- •Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety disorders.
研究组 & 干预措施
Prospective Cases
These cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s).
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Post-operative pain
时间窗: 120 minutes post-operation
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
次要结局
- Length of Hospital Stay(Through study completion, average of 1 day)