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临床试验/NCT01908491
NCT01908491已完成4 期

Comparison of the Effects of Opioid-Based Intravenous Patient Controlled Analgesia and Continuous Ropivacaine Infusion Through Wound Catheters After Repair of Pectus Excavatum

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

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

Active Comparator

hydromorphone with ketorolac

干预措施: IV PCA (Device)

Continuous wound infusion

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Eun Kim

Clinical Assistant Professor

The Catholic University of Korea

研究点 (1)

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