Opioid Free Anesthesia in Breast Cancer Surgery
关键词
抽象
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 primary outcome measures of PONV and secondary outcome measures of pain relief, analgesic requirement , incidence of chronic pain, cancer recurrence and metastasis.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 05/07/2020 |
| 提交的预估入学人数: | 05/11/2020 |
| 首次发布: | 05/14/2020 |
| 上次提交的更新: | 05/11/2020 |
| 最近更新发布: | 05/14/2020 |
| 实际学习开始日期: | 05/31/2020 |
| 预计主要完成日期: | 11/30/2020 |
| 预计完成日期: | 06/30/2021 |
状况或疾病
干预/治疗
Procedure: nerve block+opioid-free general anesthesia
Drug: nerve block+opioid-free general anesthesia
Procedure: sham bock+opioid general anesthesia
Procedure: sham bock+opioid general anesthesia
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: nerve block+opioid-free general anesthesia Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia | Procedure: nerve block+opioid-free general anesthesia Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site. |
| Sham Comparator: sham bock+opioid general anesthesia Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia | Procedure: sham bock+opioid general anesthesia Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site. |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: first diagnosis of histologically confirmed primary breast cancer; undergoing radical mastectomy; patients with I or II staging based on TNM staging system; ASA physical statue I-II; Exclusion Criteria: smoking history, chronic pain and opioid administration history; allergy to local anesthetics or NSAIDs; coagulation disorders; local infection at regional block site; a history of motion sickness, or a previous episode of PONV; unable to comply to study protocol schedule for logistic or other reasons; refusal to participate to the study |
结果
主要结果指标
1. postoperative nausea and vomiting [up to 24 hours after surgery]
次要成果指标
1. health related quality of life [up to 3 months after surgery]
2. chronic pain [up to 3 months after surgery]
3. cancer recurrence and metastasis [up to 12 months after surgery]
4. pain severity [up to 24 hours after surgery]
