ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale
研究概览
简要总结
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures.
The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The principal investigator will be unblinded. The study coordinator will be blinded, unable to access procedure notes and randomization assignment
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery
排除标准
- •Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale
研究组 & 干预措施
Group 1: Erector Spinae Plane blocks
Erector Spinae Plane blocks
干预措施: Pre-operative Erector Spinae Plane block prior to DIEP surgery (Procedure)
Group 2: Transversus Abdominis Plane blocks
Transversus Abdominis Plane blocks
干预措施: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery (Procedure)
结局指标
主要结局
Numerical Rating Scale
时间窗: 24 hours post injection
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Mean Morphine Equivalents
时间窗: 24 hours post injection
Amount of opioid pain medications administered and converted to morphine equivalents
次要结局
- Michigan Body Map(24 hours post injection)
- Numerical Rating Scale(6 months post-operation)
- Mean Morphine Equivalents(48 hours post injection)
研究者
Tara Notarianni, DO
Principal Investigator
University of Kansas Medical Center
