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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Post-thoracotomy Pain Drug: Ketamine Drug: ketamine free Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : April 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of pain 3 months after surgery [ Time Frame: 3 months after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017393


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT01017393     History of Changes
Other Study ID Numbers: JHBahk_epidural ketamine PTPS
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009

Keywords provided by Seoul National University Hospital:
preemptive epidural ketamine
prevention of chronic post-thoracotomy pain

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action