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

November 19, 2009 updated by: Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketamine
epidural ketamine added to the patient controlled epidural analgesia regimen
Drug: Ketamine
Active Comparator: ketamine free
epidural ketamine NOT added to the patient controlled epidural analgesia regimen
Drug: ketamine free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of pain 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 19, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHBahk_epidural ketamine PTPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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