Peak Plasma Levels of Bupivacaine After an Erector Spinae Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximal plasma concentration (Cmax) of bupivacaine after erector spinae block
研究概览
简要总结
The primary objective of the study is to measure plasma levels of bupivacaine following erector spinae (ESP) regional block in patients undergoing mastectomy.
详细描述
Breast cancer is one of the most frequent types of cancer in women. Mastectomy is important in treating these cases; however, sometimes it is associated with acute and chronic pain. Multimodal analgesia, combining drug therapy and regional anesthesia, can help in preventing acute and perhaps chronic pain in breast cancer patients undergoing mastectomy.
Erector spinae block is a new regional anesthesia technique that has emerged to treat thoracic pain following thoracic and breast surgery. It consists of injecting local anesthetics in the space located between the erector and paravertebral muscles using ultrasound guidance. The injection can be done at the level of T5 allowing distribution of the drug to upper and lower dermatomes.
The dose of local anesthetic injected after erector spinae block should aim to maximize analgesia while minimizing the chance of toxic systemic concentrations. Defining the rate of absorption of local anesthetics into the blood after an erector spinae block will therefore help anesthesiologists determinate optimal analgesic doses, in terms of both safety and effectiveness.
This observational study will determine bupivacaine pharmacokinetics after single shot erector spinae block with bupivacaine, to further define the right dose and duration of surveillance in post-anesthesia care.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Undergoing unilateral mastectomy under erector spinae block and general anesthesia
排除标准
- •Patient's refusal or inability to consent
- •Allergy, hypersensibility or resistance to local anesthetic
- •Contra-indication to regional anesthesia: infection in the designated area, acquired or congenital coagulopathy
- •Severe hepatic or renal insufficiency (GFR<30 mL/min)
结局指标
主要结局
Maximal plasma concentration (Cmax) of bupivacaine after erector spinae block
时间窗: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be collected to further analyze plasmatic bupivacaine values at these timepoints.
The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
次要结局
- Time (Tmax) to maximum plasma concentration Cmax of bupivacaine(The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be performed to further analyze plasmatic bupivacaine values at these timepoints.)
- Sensory block level 30 minutes after arriving to Post-Anesthesia Care Unit(30 minutes after arriving to Post-Anesthesia Care Unit)
- Post-operative pain using verbal numerical rating scale(30 minutes after arriving to Post-Anesthesia Care Unit)
- Total opioid dose needed during Post-Anesthesia Care Unit stay (PACU)(After the surgery, from the entry in the Post-Anesthesia Care Unit to the discharge from the Post-Anesthesia Care Unit, for an average of one-hour stay.)