Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.

This study has been terminated.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: July 30, 2008
Last updated: August 27, 2014
Last verified: August 2014
Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.

Condition Intervention
Drug: ketamine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.

Resource links provided by NLM:

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months [ Time Frame: 24 months ]
  • To estimate the effect of the association ketamine IV thoracic epidural on the incidence of the urinary side effects and hémodynamiques of the epidural [ Time Frame: 24 months ]

Enrollment: 21
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drip of physiological serum
Drug: placebo
physiological serum
Active Comparator: 2
Drip of ketamine
Drug: ketamine
ketamine with various concentrations

Detailed Description:
In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject between 18 and 85 years
  • subject of both sexes
  • subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
  • subject operated in settled surgery

Exclusion Criteria:

  • Against indication in the epidural insanity,
  • confusionnel, patient psychotic
  • treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)
  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 identifier: NCT00726258

Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite
Marseille, France, 13009
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: Françoise GAILLAT, MD Assistance Publique des Hôpitaux de Marseille
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT00726258     History of Changes
Other Study ID Numbers: 2007-00336-20
Study First Received: July 30, 2008
Last Updated: August 27, 2014

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017