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

Thoracotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00726258
• Other study ID #: 2007-00336-20
• Secondary ID: 2007-04
• Status: Terminated
• Phase: N/A
• First received: July 30, 2008
• Last updated: August 27, 2014
• Start date: March 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thoracotomy

Intervention

Drug:
• ketamine
ketamine with various concentrations
• placebo
physiological serum

Locations

Country	Name	City	State
France	Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural		24 months	No
Secondary	To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months		24 months	No
Secondary	To estimate the effect of the association ketamine IV thoracic epidural on the incidence of the urinary side effects and hémodynamiques of the epidural		24 months	No