Comparison of IV PCA and Wound Infusion After Repair of Pectus Excavatum

Phase 4

Completed

• Conditions: Pain; Side Effects
• Interventions: Device: IV PCA; Device: Continuous wound infusion

• Registration Number: NCT01908491
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients undergoing the repair of pectus excavatum

Exclusion Criteria

• allergy to opioid or local anesthetics
• reoperation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV PCA	IV PCA	hydromorphone with ketorolac
Continuous wound infusion	Continuous wound infusion	ON-Q Painbuster with ropivacaine

Primary Outcome Measures

Name	Time	Method
Changes of pain score	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects	during 48 hours after surgery	Number of patients who developed nausea, vomiting, sedation, respiratory depression,or wound catheter related complications are recorded.

Trial Locations

Locations (1)

Seoul St. Mary's Hospital, the Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of