Ketamine Associated With Morphine PCA After Total Hip Arthroplasty - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00797264

Purpose

Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.

We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.

Condition	Intervention
Arthroplasty, Replacement, Hip	Drug: Ketamine-Morphine Drug: Morphine Drug: Postoperative PCA of Ketamine and morphine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty

Resource links provided by NLM:

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Morphine consumption in PACU and in hospitalisation room [ Time Frame: at 24 and 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Postoperative Visual Analogic Score of pain [ Time Frame: in Recovery Room, at 24 and 48 hours, in the ward ] [ Designated as safety issue: No ]
Postoperative Measure of mechanical hyperalgesia by Von Frey filament device [ Time Frame: 24 and 48 hours in the ward ] [ Designated as safety issue: No ]
Postoperative measure Ketamine and Nor-Ketamine blood levels [ Time Frame: at 24 and 48 hours in the ward ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Ketamine pre and per operative, and morphine postoperative	Drug: Ketamine-Morphine Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
B: Active Comparator NaCl pre and per operative, and morphine postoperative	Drug: Morphine Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
C: Experimental Ketamine and morphine postoperative	Drug: Postoperative PCA of Ketamine and morphine Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)

Detailed Description:

Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

total hip arthroplasty

Exclusion Criteria:

pre operative opioid administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797264

Contacts

Contact: Philippe SITBON, MD

+33(0)-1 45213447

philippe.sitbon@bct.aphp.fr

Locations

France
Service d'anesthesie-reanimation - Hôpital Bicêtre	Recruiting
Le Kremlin Bicêtre, France, 94270
Contact: Philippe SITBON, MD +33(0)-1 4521 3447 philippe.sitbon@bct.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Philippe SITBON, MD

Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Yannick Vacher )
Study ID Numbers:	P060402
Study First Received:	November 24, 2008
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00797264 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Ketamine
Morphine
PCA
Hyperalgesia
Nor-ketamine

Additional relevant MeSH terms:

Anesthetics, Intravenous
Morphine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Excitatory Amino Acid Agents
Anesthetics, Dissociative

Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Ketamine
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 08, 2010