Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- pain assessment
研究概览
简要总结
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
详细描述
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used :
Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
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
- Single (Investigator)
盲法说明
Randomization Will be Done Using Computer Generated Tables
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-70 years.
- •Sex: females
- •ASA physical status: I-II.
- •Operation: major breast surgery
排除标准
- •- Patient refusal.
- •History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
- •Coagulation disorders.
- •Infection at the puncture site
- •Allergy to study medications.
- •Chronic use of pain medications.
- •Respiratory tract in¬fection within the last 2 weeks.
- •Neurological deficit
研究组 & 干预措施
Bupivacaine fentanyl group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
干预措施: Bupivacaine (Drug)
Bupivacaine fentanyl group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
干预措施: Fentanyl (Drug)
Bupivacaine dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block
干预措施: Dexamethasone (Drug)
Bupivacaine dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block
干预措施: Bupivacaine (Drug)
Bupivacaine fentanyl dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
干预措施: Fentanyl (Drug)
Bupivacaine fentanyl dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
干预措施: Dexamethasone (Drug)
Bupivacaine fentanyl dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
干预措施: Bupivacaine (Drug)
结局指标
主要结局
pain assessment
时间窗: one day postoperatively
Pain assessment by the aid of Visual analogue scale (VAS) Ranging from 0=no pain, 10=excruciating pain higher values represent worse outcome
Time to first analgesic request
时间窗: one day postoperative
次要结局
未报告次要终点