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

The Catholic University of Korea

Status and phase: Completed; Phase 4

Conditions: Pain; Side Effects

Treatments: Device: Continuous wound infusion; Device: IV PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT01908491

pectus-pain study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing the repair of pectus excavatum

Exclusion criteria

• allergy to opioid or local anesthetics
• reoperation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

IV PCA

Active Comparator group

Description:

hydromorphone with ketorolac

Treatment:

Device: IV PCA

Continuous wound infusion

Experimental group

Description:

ON-Q Painbuster with ropivacaine

Treatment:

Device: Continuous wound infusion