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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Side Effects
• Intervention / Treatment: Device: IV PCA; Device: Continuous wound infusion

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-040
    • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing the repair of pectus excavatum

Exclusion Criteria:

• allergy to opioid or local anesthetics
• reoperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV PCA; hydromorphone with ketorolac	Device: IV PCA; 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.
Experimental: Continuous wound infusion; ON-Q Painbuster with ropivacaine	Device: Continuous wound infusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of pain score	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.	during 48 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Jeong Eun Kim, MD, PhD, Seoul St. Mary's Hospital, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: patient controlled analgesia; wound catheter infusion; postoperative pain control; pectus excavatum; pain score
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: pectus-pain study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No