Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- quality of recovery
研究概览
简要总结
A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.
详细描述
Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.
The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
- •ASA physical statue I-II;
排除标准
- •chronic pain and opioid administration history;
- •allergy to local anesthetics or NSAIDs;
- •coagulation disorders;
- •local infection at regional block site;
- •unable to comply to study protocol schedule for logistic or other reasons;
- •refusal to participate to the study；
- •breast reconstruction with implants or latissimus dorsi flap
研究组 & 干预措施
nerve block+opioid-free general anesthesia
Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia
干预措施: paravertebral block (Procedure)
nerve block+opioid-free general anesthesia
Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia
干预措施: opioid free anesthesia (Drug)
sham bock+opioid general anesthesia
Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia
干预措施: sham block (Procedure)
sham bock+opioid general anesthesia
Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia
干预措施: opioid general anesthesia (Procedure)
结局指标
主要结局
quality of recovery
时间窗: 24 hours after surgery
15-item 15-item 15-item quality of recovery questionnaire
次要结局
- health related quality of life(up to 3 months after surgery)
- cancer recurrence and metastasis(up to 12 months after surgery)
- postoperative pain(up to 3 months after surgery)
研究者
Yi Feng, MD
Chief of the Anesthesiology Department
Peking University People's Hospital