Single-injection ultrasound guided erector spinae block compared to general anaesthesia in in patients undergoing Accelerated Partial Breast Irradiation-A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Discharge from PACU as assessed by PADSS more than equal to 9 after end of surgery.
研究概览
简要总结
Breast cancer is aworldwide problem, accounting for 10.4% of all cancer incidence among women,making it the second most common type of non-skin cancer (after lung cancer)and the fifth most common cause of cancer death. The ‘surveillance, epidemiology andend results’ (SEER) program reported that in 2006, 60% of diagnosed breastcancers are early stage. The management of early-stagebreast cancer includes breast-conservingsurgery (such as lumpectomy), a mastectomy (also called a modified radicalmastectomy), radiation therapy and systemic treatments.
Despite theadvantages of BCT, its utilization remains a problem due to convenience, access, cost and other logistical issues. In APBI, radiation can bedelivered in a significantly shortened period, thereby potentially making theBCT option available and attractive to more women. APBI can be done undereither local anaesthesia, general anaesthesia or regional blocks with sedation.Breast cancer surgery, such as mastectomy or lumpectomy with or withoutaxillary lymph node dissection/biopsy, has frequently been performed usinggeneral anesthesia (GA). However, GA is associated with a high incidence of postoperativenausea and vomiting (PONV) that not only reduces patient satisfaction but alsodelays patient recovery after breast surgery. Recently,breast cancer surgery has often been performed under regional anesthesiatechniques like Paravertebral block (PVB), erector spinae block etc. Arecent metaanalysis demonstrated that thoracic PVB has several advantages, suchas better postoperative pain control, lower incidence of PONV, shorter recoverytime and higher patient satisfaction, compared with GA alone in breast surgery. To our knowledge, however, there are no reports of studies comparing GA withErector Spinae block for Accelerated Partial Breast Irradiation. The firstpurpose of this study is to compare these two anesthesia techniques interms of post-anesthesia recovery time. Our secondary aim was to compare perioperativehemodynamics because decreasing blood pressure is often observed during GA. Wehypothesized that performing the procedure under Erector Spinae block could facilitate postoperativerecovery and avoid hypotension during anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- Female
入选标准
- •Clinical diagnosis of early stage breast cancer for APBI.
- •ASA Physical status I, II, III.
排除标准
- •Patients Refusal b.
- •Patients with infection at the site of ESPB.
- •Patients with severe chest wall deformity.
- •Patients with history suggestive of coagulopathy or receiving any anticoagulants.
- •Presence of complications like mental illness, severe heart disease (NYHA classification ≥3), any renal or hepatic disorder before surgery.
- •Allergic to any drug being used during the study.
结局指标
主要结局
Discharge from PACU as assessed by PADSS more than equal to 9 after end of surgery.
时间窗: Discharge from PACU as assessed by PADSS more than equal to 9 at regular intervals time 0,1,2,4 hrs.
次要结局
- Postoperative pain VAS score(Postoperative Nausea vomiting( VAS score 30 mm))
