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:

Drug Information available for: Ketamine hydrochloride Ketamine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on February 27, 2015

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