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

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ClinicalTrials.gov Identifier: NCT01017393
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE November 19, 2009
First Posted Date  ICMJE November 20, 2009
Last Update Posted Date November 20, 2009
Study Start Date  ICMJE April 2004
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
Incidence of pain 3 months after surgery [ Time Frame: 3 months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Chronic Post-thoracotomy Pain
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: ketamine free
Study Arms  ICMJE
  • Experimental: ketamine
    epidural ketamine added to the patient controlled epidural analgesia regimen
    Intervention: Drug: Ketamine
  • Active Comparator: ketamine free
    epidural ketamine NOT added to the patient controlled epidural analgesia regimen
    Intervention: Drug: ketamine free
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2009)
209
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01017393
Other Study ID Numbers  ICMJE JHBahk_epidural ketamine PTPS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP