Clinical Trials Directory

Trials / Completed

CompletedNCT01908491

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
80 (actual)
Sponsor
The Catholic University of Korea · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEIV PCAOn arrival in the postanesthetic care unit, a patient-controlled analgesia (IV PCA) was connected to the iv catheter. The PCA regimen consisted of hydromorphone (2 mcg/kg/hr) and ketorolac (0.02 mg/kg/hr) with normal saline (total volume 100ml). PCA was programmed to deliver 1 ml/hr as background infusion and 1 ml per demand with a 10 min lockout during 48 hr period.
DEVICEContinuous wound infusionPatients underwent insertion of wound catheters by the surgeon just before the closure of incision site. The wound catheters, consisting of double branch and connected to elastomeric pump filled with ropivacaine (0.15\~0.25%) and administered at a constant flow rate of 2 ml/hr in each branch of the catheter for 48 hr.

Timeline

Start date
2012-10-01
Primary completion
2013-10-01
Completion
2013-10-01
First posted
2013-07-25
Last updated
2013-11-14

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01908491. Inclusion in this directory is not an endorsement.