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

NCT ID: NCT01908491

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Pain Side Effects

Keywords

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patient controlled analgesia wound catheter infusion postoperative pain control pectus excavatum pain score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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IV PCA

hydromorphone with ketorolac

Group Type ACTIVE_COMPARATOR

IV PCA

Intervention Type 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

ON-Q Painbuster with ropivacaine

Group Type EXPERIMENTAL

Continuous wound infusion

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing the repair of pectus excavatum

Exclusion Criteria

* allergy to opioid or local anesthetics
* reoperation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jeong Eun Kim

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Eun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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pectus-pain study

Identifier Type: -

Identifier Source: org_study_id