Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Postoperative Narcotic Use
研究概览
简要总结
The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery. The two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control is essential following any major operative procedure. A variety of methods have been used to ensure adequate pain control, each with its own advantages and risks. Increasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications. Proposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus.
详细描述
The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques. The most common regional block used to achieve postoperative analgesia following mastectomy is the paravertebral block, during which local anesthetic is injected into the paravertebral space which contains the thoracic spinal nerves, between the costotransverse ligament and the pleura. At our institution there has been recent interest in an alternative regional block. The pectoral nerve block is performed by injecting anesthetic between the pectoralis major and the pectoralis minor (PECs I) or between the pectoralis minor and the serratus anterior (PEC II).
The proposed advantage of the pectoral nerve block for regional anesthesia during breast surgery is equal analgesic efficacy with fewer potential complications.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥ 18 years of age
- •Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
- •Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
- •Patient agrees to participate in the study and signs informed consent
排除标准
- •Neoadjuvant radiation therapy
- •Stage IV cancer
- •Previous breast surgery (excluding percutaneous biopsies of all types)
- •History of either PVB or PEC procedures
- •Planned general anesthesia use during surgery
- •Allergies to ropivacaine, midazolam, fentanyl, or propofol
- •Pregnant women
- •Prisoners
- •Adults unable to consent
- •Non-English-speaking patients
研究组 & 干预措施
Paravertebral Block
The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
干预措施: Paravertebral Block (Drug)
Pectoral Nerve Block
The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
干预措施: Pectoral Nerve Block (Drug)
结局指标
主要结局
Postoperative Narcotic Use
时间窗: First 24 hours post-PACU (or until discharge)
Participants for whom Narcotics were used postoperatively
Intraoperative Narcotic Use
时间窗: intraoperatively, average of about 1 hour
Participants for whom Narcotics were used for pain during surgery
Post Anesthesia Care Unit (PACU) Narcotic Use
时间窗: in PACU, generally 1-3 hours
Participants for whom Narcotics were used in PACU
次要结局
- Pain Control Measured by Pain Scale(2 weeks postoperative)
- Pain Control Measured by Length of Operation(intraoperative)
- Pain Control Measured by Estimated Blood Loss(intraoperative)
- Participants With Postoperative Nausea(2 weeks postoperative)
- Pain Control Measured by the Use of Pain Pills Postoperatively(2 weeks postoperative)
- Pain Control Measured by Calls to Physicians Office Relating to Pain(2 weeks postoperative)