2022-501312-34-00撤回4 期
The Intertransverse Process Block for Minor Breast Cancer Surgery – Single or Multiple Injection? A randomised, procedure related, blinded clinical trial.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes
研究概览
简要总结
The main objective is to determine the clinical efficacy of the intertransverse process block.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for day case elective unilateral minor breast cancer (including DCIS) surgery
- •Age ≥ 18 years at the date of inclusion
- •American Associations of Anaesthesiologist (ASA) class I-III
- •Have received thorough information, orally and in written form, and signed the “Informed Consent” form on participation in the study.
- •Weight > 52,5 kilograms (chosen due to the maximum single dose of Ropivacaine (3mg/kg))
排除标准
- •Substantial co-morbidity: American Associations of Anaesthesiologist (ASA) class > III
- •Any systemic muscular or neuromuscular disease
- •Any use of vasodilatory substance (investigators decision)
- •Local infection at the site of injection or systemic infection
- •Difficult sonoanatomical visualisation of the target area (SCTL, ITTC etc.) necessary for the block execution
- •Severe hypovolemia
- •Pregnant or breastfeeding
- •Inability to speak and understand Danish
- •Inability to cooperate
- •Allergy to study drugs
- •Daily intake of analgesics (investigators decision)
- •Alcohol and/or drug overuse (investigators decision)
- •Previous thoracic trauma or thoracic surgery
- •Previous/current piercing of the nipple of any kind on blockade side
- •Tattoos on the thorax (according to the investigators decision)
结局指标
主要结局
The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes
The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes
次要结局
- “Sensory mapping”: the extent of cutaneous spread of the sensory block (area in cm2)
- To evaluate thermography in a clinical setup (the temperature differences between non-blockade side and blockade side)
- To evaluate changes in non-invasive blood pressure
- To evaluate block application numeric rating scale scores
研究者
Jens Børglum
Scientific
Zealand University Hospital
研究点 (1)
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