Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
July 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 28, 2014
August 1, 2014
2.3 years
July 30, 2008
August 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
1
PLACEBO COMPARATORDrip of physiological serum
2
ACTIVE COMPARATORDrip of ketamine
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite
Marseille, 13009, France
Related Publications (1)
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.
PMID: 22790008DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Françoise GAILLAT, MD
Assistance Publique des Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2008
First Posted
July 31, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
August 28, 2014
Record last verified: 2014-08