Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- pain score: visual number scale
研究概览
简要总结
The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for not reconstructive unilateral breast surgery.
- •Physical status American Society Anesthesiologists (ASA) I-III.
- •Signed informed consent.
- •Aged between 18 and 75 years.
- •Ability to assess pain using a verbal and numerical scales.
- •Assessment of pain at the time of inclusion in the study is lower than 3 verbal simple scale
排除标准
- •Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence.
- •Local infection at the site of the puncture or to puncture prior systemic.
- •Contraindications to study medication.
- •Muscle or neurological disease, peripheral or central.
- •Patients with prior history of opioid.
- •Pregnancy or lactation.
- •Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments)
- •Active Chronic alcoholism or drug addiction.
- •BMI under 20 or mayor
- •Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids.
- •Rejection of the patient
研究组 & 干预措施
BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
干预措施: BRILMA (Procedure)
BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
干预措施: dexketoprofen (Drug)
BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
干预措施: paracetamol (Drug)
paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
干预措施: paravertebral block (Procedure)
paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
干预措施: dexketoprofen (Drug)
paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
干预措施: paracetamol (Drug)
结局指标
主要结局
pain score: visual number scale
时间窗: 0, 3, 6,12, 18, 24h
post-admission to PACU
pain score: verbal simple scale
时间窗: 0,3,6,12,18 and 24h
admission to post-anesthesia care unit (PACU)
opioid requirements
时间窗: 24 h
0 dose/ 1 dose/ 2 or more doses
sleep quality
时间窗: 24 h
bad/regular/good
amount of sleep
时间窗: 24 h
\< 3h/ 3-6h, \>6h
次要结局
- Number of Participants with Serious and Non-Serious Adverse Events(24 h)
- percentage of participants with nausea and vomiting(24 hours)
研究者
Paula Diéguez García
anesthesiologist
Complexo Hospitalario Universitario de A Coruña