Clinical trial NCT01908491: Comparison of IV PCA and Wound Infusion After Repair of Pectus Excavatum
Official title: Comparison of the Effects of Opioid-Based Intravenous Patient Controlled Analgesia and Continuous Ropivacaine Infusion Through Wound Catheters After Repair of Pectus Excavatum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Side Effects
Keywords: patient controlled analgesia
wound catheter infusion
postoperative pain control
pectus excavatum
pain score
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing the repair of pectus excavatum

Exclusion Criteria:

* allergy to opioid or local anesthetics
* reoperation

Primary outcomes:
measure: Changes of pain score
timeFrame: during 48 hours after surgery
Secondary outcomes:
measure: Incidence of side effects
timeFrame: during 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, the Catholic University of Korea
Study officials:
affiliation: Seoul St. Mary's Hospital, the Catholic University of Korea
name: Jeong Eun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: