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

Primary Purpose

Pain, Side Effects

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IV PCA
Continuous wound infusion
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring patient controlled analgesia, wound catheter infusion, postoperative pain control, pectus excavatum, pain score

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing the repair of pectus excavatum

Exclusion Criteria:

  • allergy to opioid or local anesthetics
  • reoperation

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IV PCA

Continuous wound infusion

Arm Description

hydromorphone with ketorolac

ON-Q Painbuster with ropivacaine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2013
Last Updated
November 13, 2013
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01908491
Brief Title
Comparison of IV PCA and Wound Infusion After Repair of Pectus Excavatum
Official Title
Comparison of the Effects of Opioid-Based Intravenous Patient Controlled Analgesia and Continuous Ropivacaine Infusion Through Wound Catheters After Repair of Pectus Excavatum
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Side Effects
Keywords
patient controlled analgesia, wound catheter infusion, postoperative pain control, pectus excavatum, pain score

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV PCA
Arm Type
Active Comparator
Arm Description
hydromorphone with ketorolac
Arm Title
Continuous wound infusion
Arm Type
Experimental
Arm Description
ON-Q Painbuster with ropivacaine
Intervention Type
Device
Intervention Name(s)
IV PCA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous wound infusion
Intervention Description
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 Outcome Measure Information:
Title
Changes of pain score
Description
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.
Time Frame
during 48 hours after surgery
Secondary Outcome Measure Information:
Title
Incidence of side effects
Description
Number of patients who developed nausea, vomiting, sedation, respiratory depression,or wound catheter related complications are recorded.
Time Frame
during 48 hours after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing the repair of pectus excavatum Exclusion Criteria: allergy to opioid or local anesthetics reoperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Eun Kim, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital, the Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital, the Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of

12. IPD Sharing Statement

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

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