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NCT Number: NCT01908491

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

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.

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Key information

Conditions

Pain Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Side Effects Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul St. Mary's Hospital, the Catholic University of Korea

Seoul, 137-040, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing the repair of pectus excavatum

Exclusion criteria

  • allergy to opioid or local anesthetics
  • reoperation

Treatment and study plan

IV PCA

Device

On 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.

Continuous wound infusion

Device

Patients 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.

Primary outcomes

  1. Changes of pain score

    Time frame: 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 outcomes

  1. Incidence of side effects

    Time frame: during 48 hours after surgery

    Number of patients who developed nausea, vomiting, sedation, respiratory depression,or wound catheter related complications are recorded.

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2013
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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