Ketamine Associated With Morphine PCA After Total Hip Arthroplasty (KETAMINE)

April 10, 2013 updated by: Assistance Publique - Hôpitaux de Paris

Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin Bicêtre, France, 94270
        • Service d'anesthesie-reanimation - Hôpital Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • total hip arthroplasty

Exclusion Criteria:

  • pre operative opioid administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Ketamine pre and per operative, and morphine postoperative
Drug: Ketamine-Morphine
Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
Other Names:
  • Ketamine pre and per operative, and morphine postoperative
Active Comparator: B
NaCl pre and per operative, and morphine postoperative
Drug: Morphine
Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
Experimental: C
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)
Other Names:
  • Ketamine Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morphine consumption in PACU and in hospitalisation room
Time Frame: at 24 and 48 hours
at 24 and 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative Visual Analogic Score of pain
Time Frame: in Recovery Room, at 24 and 48 hours, in the ward
in Recovery Room, at 24 and 48 hours, in the ward
Postoperative Measure of mechanical hyperalgesia by Von Frey filament device
Time Frame: 24 and 48 hours in the ward
24 and 48 hours in the ward
Postoperative measure Ketamine and Nor-Ketamine blood levels
Time Frame: at 24 and 48 hours in the ward
at 24 and 48 hours in the ward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Philippe SITBON, MD, Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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