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

Not Applicable

Terminated

• Conditions: Thoracotomy
• Interventions: Drug: placebo; Drug: ketamine

• Registration Number: NCT00726258
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-07-31
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	Drip of physiological serum
2	ketamine	Drip of ketamine

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months	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	24 months

Trial Locations

Locations (1)

Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite; 🇫🇷 Marseille, France