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临床试验/NCT06091241
NCT06091241招募中不适用

ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

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

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

Other

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tara Notarianni, DO

Principal Investigator

University of Kansas Medical Center

研究点 (2)

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