Ketamine Associated With Morphine PCA After Total Hip Arthroplasty

Ketamine

Brief Summary

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.

Intervention / Treatment

  • Ketamine-Morphine (DRUG)
    Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
  • Morphine (DRUG)
    Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
  • Postoperative PCA of Ketamine and morphine (DRUG)
    Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)

Condition or Disease

  • Arthroplasty, Replacement, Hip

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 18 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Nov 01, 2008
    Primary Completion: Oct 01, 2010 ACTUAL
    Completion Date: Oct 01, 2010 ACTUAL
    Study First Posted: Nov 25, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 10, 2013

    Sponsors / Collaborators

    Lead Sponsor: Assistance Publique - Hôpitaux de Paris
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Le Kremlin Bicêtre, Île-de-France, France

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

    Participant Groups

    • Ketamine pre and per operative, and morphine postoperative

    • NaCl pre and per operative, and morphine postoperative

    • Ketamine and morphine postoperative

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * total hip arthroplasty

    Exclusion Criteria:

    * pre operative opioid administration

    Primary Outcomes
    • Morphine consumption in PACU and in hospitalisation room at 24 and 48 hours
    Secondary Outcomes
    • Postoperative Visual Analogic Score of pain in Recovery Room, at 24 and 48 hours, in the ward
    • Postoperative Measure of mechanical hyperalgesia by Von Frey filament device 24 and 48 hours in the ward
    • Postoperative measure Ketamine and Nor-Ketamine blood levels at 24 and 48 hours in the ward

    More Details

    NCT Number: NCT00797264
    Acronym: KETAMINE
    Other IDs: P060402
    Study URL: https://clinicaltrials.gov/study/NCT00797264
    Last updated: Sep 29, 2023