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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00726258
First received: July 30, 2008
Last updated: January 29, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Thoracotomy
 Drug: ketamine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726258

Contacts
Contact: Françoise GAILLAT, MD 0491744634 fgaillat@mail.ap-hm.fr

Locations
France
Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite Recruiting
Marseille, France, 13009
Contact: Françoise GAILLAT, MD     0491744634     fgaillat@mail.ap-hm.fr    
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Françoise GAILLAT, MD Assistance Publique des Hôpitaux de Marseille
  More Information

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00726258     History of Changes
Other Study ID Numbers: 2007-00336-20, 2007-04
Study First Received: July 30, 2008
Last Updated: January 29, 2010
Health Authority: France: Ministry of Health

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