Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
研究概览
简要总结
The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.
详细描述
The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.
Standard of care intervention is preoperative PECS-II blocks versus Intraoperative Pectoral Blocks.
The medication used are standard of care and include Bupivacaine and liposomal bupivacaine. Bupivacaine is FDA approved and indicated for the local or regional anesthesia or analgesia for surgery procedures and therapeutic procedures. Liposomal bupivacaine is FDA approved and indicated for adults to produce postsurgical local analgesia and as nerve block to produce postsurgical regional analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients who are 18 years of age or older
- •Patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at UCMC for breast cancer or high-risk of breast cancer. Patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., BRCA1, BRCA2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator.
排除标准
- •Patients undergoing only a partial mastectomy or tissue-based reconstruction.
- •Non-English speaking.
- •Patients who are pregnant.
- •Patients with an allergy to local anesthetics
- •Except: patients with allergies only to topical anesthetics may be included.
- •Patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. Patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement.
- •Patients with a history of opioid use disorder.
- •Inability to provide informed consent.
- •Patients who otherwise in the opinion of the Investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).
研究组 & 干预措施
3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP)
Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle with superior anesthetic as determined by stage I, after mastectomy completion and prior to reconstruction, if performed, or wound closure.
干预措施: Intraoperative Pecs II block (IOB) & superior AT (EX or BP) (Procedure)
结局指标
主要结局
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
时间窗: 14 days post-operation
Post-operative opioid usage as measured by total inpatient and outpatient opioid use (oral morphine milliequivalents) through 14 days post-op.
Postoperative pain as indicated by postoperative opioid use discontinuation
时间窗: 14 days post-operation
Post-operative opioid usage as measured by time to opiate discontinuation through 14 days post-op.
次要结局
- Post-operative pain scores indicated by patient report Numeric Rating Scale(21 days Post Operation)
- Post-operative pain scores indicated by patient survey(21 days Post Operation)
- Patient satisfaction indicated by patient report(21 days Post Operation)
- Intraoperative procedure time measured as from time of incision to start of closing(Day 0: Surgery)
- Intraoperative opioid administration measured in Milliequivalents(Day 0: Surgery)
- Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time(Day 0: Surgery)
- Postoperative length of stay as measured by the number of nights spent in the hospital after surgery.(Day 0-7)
研究者
Alicia Heelan
Principal Investigator
University of Cincinnati