Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 48
- 主要终点
- Summed pain intensity
研究概览
简要总结
Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, 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
- •At least 1 year after surgery for breast cancer
- •Women aged 18 or over
- •Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over)
排除标准
- •Previous cosmetic surgery
- •bilateral cancer
- •pregnant or lactating
- •other disease in the nervous system
- •in treatment for psychiatric disease
- •unable to understand Danish
- •unable to give informed concent
研究组 & 干预措施
ICBN, active
Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN
干预措施: Bupivacaine (Drug)
ICBN, placebo
Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN
干预措施: NaCl (Drug)
Tenderpoint, active
Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint
干预措施: Bupivacaine (Drug)
Tenderpoint, placebo
Ultrasound guided injection of NaCl, 20mL in the tenderpoint
干预措施: NaCl (Drug)
结局指标
主要结局
Summed pain intensity
时间窗: At least 1 year after surgery
The summed pain intensity (of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)) 0-30
次要结局
- Pain at rest, pain during movement and pressure pain(At least 1 year after surgery)
- Pain related reduction of physical function(At least 1 year after surgery)
研究者
Kenneth Geving Andersen
Research fellow
Rigshospitalet, Denmark