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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01017393
First received: November 19, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention
Chronic Post-thoracotomy Pain
 Drug: Ketamine
Drug: ketamine free

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Incidence of pain 3 months after surgery [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 209
Study Start Date: April 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 81 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017393

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01017393     History of Changes
Other Study ID Numbers: JHBahk_epidural ketamine PTPS
Study First Received: November 19, 2009
Last Updated: November 19, 2009
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013