Preemptive Efficacy of Stellate Ganglion Block for Prevention of Post Mastectomy Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- incidence of postmastectomy depression
研究概览
简要总结
Complications after mastectomy include chronic pain and depression.
详细描述
A mastectomy is surgery could be associated with complications include chronic pain and depression. In female breast cancer patients, the incidence of postoperative depression was 46.55%. Stellate ganglion block had been used for treating post-traumatic stress disorder (PTSD) and depression symptoms even in its prevention. Also, it used in treatment of chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Age ranging from 18 to 65 years
- •American Society of Anesthesiologists (ASA) no more than II
- •Had unilateral cancer breast
- •Scheduled to do unilateral modified radical mastectomy
排除标准
- •Pregnant female
- •Existing Horner syndrome
- •Had any neuromuscular disease
- •Had allergy to local anesthetics
- •History of use of analgesics
- •Had any deformity or a previous surgery in the neck or ipsilateral arm or breast
- •Had any contraindication to the procedure (coagulation disorders, local infection, sepsis)
- •Had any contraindication to the sympathetic blockade (decompensate cardiopulmonary or hemodynamic disorders)
- •History of psychotic disorder including depression, bipolar disorder or personality disorder
- •Patient with Beck Depression Inventory (BDI) score more than 13
研究组 & 干预措施
Stellate gangalion block group (Group S)
Patients will receive ipsilateral stellate gangalion block (4ml) bupivacaine 0.25 %+( 4ml) normal saline + (8mg) dexamethasone in a total 10 ml
干预措施: Stellate gangalion block (Procedure)
Control group (Group C)
Patients will not receive stellate gangalion block
结局指标
主要结局
incidence of postmastectomy depression
时间窗: 6 months postoperatively
Beck Depression Inventory (BDI) score
次要结局
- Any complications related to stellate ganglion injection(within 1 day postoperatively)
- acute postoperative pain at the incision site (breast and the axilla)(every 12 hour for the first 48 hour recorded)
- incidence of nausea and vomiting(during first 3 postoperative days)
- Functional pain in the ipsilateral shoulder(during the first 6 months postoperatively)
- incidence of postmastectomy depression(3 months postoperatively)
- the need for postoperative antidepressant(during the first 6 months postoperatively)
- chronic postmastectomy pain at the incision site(at 3 and 6 months postoperatively)
研究者
maha abou-zeid
Assistant Professor of Anaesthesia and Surgical Intensive Care
Mansoura University