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Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain

NCT ID: NCT01017393

Last Updated: 2009-11-20

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

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-06-30

Brief Summary

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Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded, randomized, controlled trial was to assess the effect of preemptive low-dose epidural ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic post-thoracotomy pain.

Detailed Description

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Conditions

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Chronic Post-thoracotomy Pain

Keywords

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preemptive epidural ketamine prevention of chronic post-thoracotomy pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ketamine

epidural ketamine added to the patient controlled epidural analgesia regimen

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine free

epidural ketamine NOT added to the patient controlled epidural analgesia regimen

Group Type ACTIVE_COMPARATOR

ketamine free

Intervention Type DRUG

Interventions

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Ketamine

Intervention Type DRUG

ketamine free

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing surgery with a thoracotomy incision

Exclusion Criteria

* history of previous thoracic surgery, chronic pain, psychiatric disease, cardiac or vascular disease, neurologic deficits, or contraindications to epidural catheterization such as coagulopathy, or localized or systemic infection
Minimum Eligible Age

19 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JHBahk_epidural ketamine PTPS

Identifier Type: -

Identifier Source: org_study_id