Comparison of the Effects of Opioid-Based Intravenous Patient Controlled Analgesia and Continuous Ropivacaine Infusion Through Wound Catheters After Repair of Pectus Excavatum
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes of pain score
研究概览
简要总结
Postoperative pain management is a major problem after repair of pectus excavatum.Various methods of pain management have been introduced. However, the effects of continuous wound infusion of local anesthetics through ON-Q catheters were not well evaluated in pectus surgery. Therefore, we conducted prospective randomized controlled study to compare the effects of IV PCA and continuous wound infusion after repair of pectus excavatum.
详细描述
Pain control is an important issue after correction of pectus excavatum. Insufficient pain control leads to develop postoperative pulmonary complications, such as hypoxia, atelectasis and pneumonia. Additionally, hospital length of stay could be prolonged. Therefore, successful pain management is mandatory to improve clinical outcome, to decrease postoperative morbidity and to shorten the duration of hospital stay. Various methods of pain management have been introduced. Current typical methods for pain management include thoracic epidural analgesia and intravenous patient-controlled analgesia (IV PCA). Epidural analgesia has shown superior pain control effects. However, there may be rare but serious complications, such as spinal cord and nerve root lesions, epidural hematoma, or infections. IV PCA is a well-established method of postoperative pain management. However, the systemic side effects of opioid, such as nausea, vomiting, sedation, or respiratory depression may occur. Continuous wound infusion of local anesthetics through ON-Q catheters is another method for pain management. It has been used for various surgical procedures. However, the effect is not well evaluated in pectus surgery. The purpose of this study is to compare the effects of opioid-based IV PCA and continuous wound infusion using a catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing the repair of pectus excavatum
排除标准
- •allergy to opioid or local anesthetics
- •reoperation
研究组 & 干预措施
IV PCA
hydromorphone with ketorolac
干预措施: IV PCA (Device)
Continuous wound infusion
ON-Q Painbuster with ropivacaine
干预措施: Continuous wound infusion (Device)
结局指标
主要结局
Changes of pain score
时间窗: during 48 hours after surgery
Pain score was measured by the Wong-Baker FACES pain scale at 1, 2, 6, 24, 48 hours after surgery. Pain scale consists of 6 faces with word descriptors and numbers from 0 to 10. The child look at the faces, the nurse or parent uses the words to describe the expression, and the child is asked to point to the face that describes how he/she feels. The number is used to record a pain score. This simple and quick scale can be easily reproduced for use at the bed-side with children as young as 3 years of age.
次要结局
- Incidence of side effects(during 48 hours after surgery)
研究者
Jeong Eun Kim
Clinical Assistant Professor
The Catholic University of Korea
