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CompletedNCT01017393Updated Nov 20, 2009

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

An interventional study of Ketamine and ketamine free in Chronic Post-thoracotomy Pain, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 81 Years. Per ClinicalTrials.gov, last updated 2009-11-20.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
209
Allocation
Randomized
Ages
19 Years to 81 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Post-thoracotomy Pain

Keywords

  • preemptive epidural ketamine
  • prevention of chronic post-thoracotomy pain
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 81 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing surgery with a thoracotomy incision

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
209 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of pain 3 months after surgery

    Time frame: 3 months after surgery

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Seoul 110-744, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2004, a primary completion of Jun 2005 and a completion of Jun 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2009
First posted
Nov 20, 2009
Start
Apr 2004
Primary completionActual
Jun 2005
CompletionActual
Jun 2005
Last update
Nov 20, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01017393
First posted
Nov 20, 2009
Start date
Apr 2004
Primary completion
Jun 2005
Completion
Jun 2005
Last update
Nov 20, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ketamine

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