A Prospective Randomized Controlled Trial of Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analgesia requirements in 24 hours post op.
研究概览
简要总结
The aim of this study is to compare conventional and ultrasound guided paravertebral blocks to with respect to efficacy, patient satisfaction and complication rates.
详细描述
Adequate pain control is important in breast cancer surgery. In addition to benefits to patients, effective pain management strategies also facilitate day case surgery. Regional anaesthetic techniques, and paravertebral blocks in particular, are valuable in this sphere. The conventional method of administering this block is blind and depends on anatomical landmarks for placement. Performing the block under US guidance provides real time imaging while advancing the needle. This might allow for a more accurate placement and hence a more effective block which would enhance pain relief and minimise complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing resectional breast surgery
- •Benign or malignant indications for surgery
排除标准
- •Previous spinal surgery
- •Severe coagulopathy
- •Allergies to local anaesthesia
- •Localised infection at site of injection
研究组 & 干预措施
Standard Paravertebral Block
Patients receiving a conventional paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered using anatomical landmarks
干预措施: Ultrasound guided paravertebral block (Procedure)
Ultrasound Guided Paravertebral Block
Patients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance
干预措施: Ultrasound guided paravertebral block (Procedure)
结局指标
主要结局
Analgesia requirements in 24 hours post op.
时间窗: 24hours
Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op
次要结局
- Pain Scores(1, 2 and 24 hours post operatively and 1 week post operatively)
- Complications(Up to 2 weeks post operatively)
- Patient satisfaction(Up to 2 weeks post operatively)
研究者
Deirdre Nally
Senior Registrar in General Surgery
University College Hospital Galway