Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-op pain
研究概览
简要总结
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will be assessed.
详细描述
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block after induction of general anesthesia and prior to the start of surgery. Post-operative pain scores and post-operative pain medication usage will be recorded. Post-operative nausea/vomiting scores and post-op anti-emetic medication usage will be recorded. The clinical impact of pectoral nerve block on this expanding population of patients will be determined.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-90 years old
- •Subjects able to read and understand the informed consent
- •American Society of Anesthesiologists (ASA) physical status I and II
- •Subjects scheduled to undergo unilateral or bilateral mastectomy with immediate breast reconstruction with submuscular placement of tissue expander or permanent implant under general anesthesia, including:
- •subjects diagnosed with breast cancer
- •subjects diagnosed with atypia or other high risk proliferative breast disease
- •subjects with a family history who are considered at high risk for breast cancer (including those with hereditary or genetic predisposition)
排除标准
- •Subjects unable to read or understand the informed consent
- •ASA physical status III or IV
- •Subjects with an allergy to local anesthetic
- •Subjects with a medical contraindication to regional anesthetic, such as coagulopathy or local infection
- •Subjects with a pre-existing submuscular implant
- •Subjects scheduled to undergo mastectomy with myocutaneous flap reconstruction
- •Subjects scheduled to undergo mastectomy without immediate reconstruction
- •Subjects with a history of chronic pain or chronic opioid use
研究组 & 干预措施
GA + Pec Block
Following induction of general anesthesia, the patients in the intervention group will undergo an ultrasound-guided pectoral block. With the patient in proper position, the infraclavicular and axillary regions are prepped with chlorhexidine. An US probe is placed below the third of the clavicle over the pectoralis major muscle. After identifying the appropriate anatomical structures, a 21-gauge echogenic needle is advanced under US visualization to the tissue plane between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie and 15 mL of 0.25% bupivacaine will be deposited. In a similar manner, 20 mL of 0.25% bupivacaine will be deposited under ultrasound-guidance at the level of the third rib above the serratus anterior muscle.
干预措施: Ultrasound (Device)
GA + Pec Block
Following induction of general anesthesia, the patients in the intervention group will undergo an ultrasound-guided pectoral block. With the patient in proper position, the infraclavicular and axillary regions are prepped with chlorhexidine. An US probe is placed below the third of the clavicle over the pectoralis major muscle. After identifying the appropriate anatomical structures, a 21-gauge echogenic needle is advanced under US visualization to the tissue plane between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie and 15 mL of 0.25% bupivacaine will be deposited. In a similar manner, 20 mL of 0.25% bupivacaine will be deposited under ultrasound-guidance at the level of the third rib above the serratus anterior muscle.
干预措施: 0.25% bupivacaine (Drug)
结局指标
主要结局
Post-op pain
时间窗: within first 48 hours
post-op pain assessed by Visual Analog Scale
次要结局
- Post-op nausea/vomiting(within first 48 hours)
研究者
Jeannie Shen
Director, Breast Surgery
Huntington Memorial Hospital