Serratus Plane Block for Postoperative Pain Control After Breast Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Requirements
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-III.
- •Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.
排除标准
- •Unable to provide informed consent.
- •Patients who are pregnant or nursing.
- •ASA IV-V.
- •Alcohol or narcotic dependence in the last 2 years.
- •Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator.
- •Hepatic disease.
- •Allergies to amide anesthetics as determined from medical history or patient self-report.
- •Evidence of infection at injection site.
- •Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol.
- •Body weight <50kg.
- •BMI>40kg/m
- •History of hypotension.
- •Abnormal renal (creatinine > 1.5 mg/dL) function.
- •Heart block.
- •Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.
研究组 & 干预措施
Bupivicaine HCl
Ultrasound guided serratus plane block with bupivacaine HCl.
干预措施: Bupivicaine HCl (Drug)
Normal Saline
Placebo injection on operated side, same technique as experimental group.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Postoperative Opioid Requirements
时间窗: 4 to 10 hours
Postoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.
次要结局
- Postoperative Nausea and Vomiting With Verbal Rating Scale(every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.)
- Number of Participants Who Required Antiemetics During the Postoperative Period.(4 to 10 hours)
- PACU Length of Stay(0 to 10 hours)
- Patient Experience and Satisfaction With a 5-point Categorial Scale(1 week)
- Postoperative Pain With Numeric Rating Scale(every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.)
研究者
Judith Aronsohn, MD
Principal Investigator
Northwell Health