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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00726258
First received: July 30, 2008
Last updated: August 27, 2014
Last verified: August 2014

July 30, 2008
August 27, 2014
March 2008
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726258 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.
Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Thoracotomy
  • Drug: ketamine
    ketamine with various concentrations
  • Drug: placebo
    physiological serum
  • Placebo Comparator: 1
    Drip of physiological serum
    Intervention: Drug: placebo
  • Active Comparator: 2
    Drip of ketamine
    Intervention: Drug: ketamine
Joseph C, Gaillat F, Duponq R, Lieven R, Baumstarck K, Thomas P, Penot-Ragon C, Kerbaul F. Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study. Eur J Cardiothorac Surg. 2012 Oct;42(4):e58-65. doi: 10.1093/ejcts/ezs398. Epub 2012 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
December 2010
July 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00726258
2007-00336-20, 2007-04
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Françoise GAILLAT, MD Assistance Publique des Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
August 2014

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