search
Back to results

Intrathecal Morphine in Knee Arthroplasty

Primary Purpose

Pain, Postoperative, Arthroplasty, Replacement, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intra thecal morphine
intra thecal morphine
intra thecal morphine
Sponsored by
University College Hospital Galway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients for elective total knee arthroplasty

Exclusion Criteria:

  • No contraindication to spinal
  • No allergy to morphine, rescue analgesia or anti-emesis treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    Arm Description

    patients in this group got 100mcg of intrathecal morphine.

    patients in this group got 200 mcg intrathecal morphine

    patients in this group given 300 mcg intrathecal morphine.

    Outcomes

    Primary Outcome Measures

    pain

    Secondary Outcome Measures

    nausea and vomiting
    pruritus
    sedation

    Full Information

    First Posted
    June 9, 2008
    Last Updated
    June 9, 2008
    Sponsor
    University College Hospital Galway
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00695045
    Brief Title
    Intrathecal Morphine in Knee Arthroplasty
    Official Title
    Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University College Hospital Galway

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Arthroplasty, Replacement, Knee
    Keywords
    Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    patients in this group got 100mcg of intrathecal morphine.
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    patients in this group got 200 mcg intrathecal morphine
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    patients in this group given 300 mcg intrathecal morphine.
    Intervention Type
    Drug
    Intervention Name(s)
    intra thecal morphine
    Other Intervention Name(s)
    intraspinal morphine
    Intervention Description
    100 mcg intrathecal morphine given once .
    Intervention Type
    Drug
    Intervention Name(s)
    intra thecal morphine
    Other Intervention Name(s)
    intra spinal morphine
    Intervention Description
    200 mcg intrathecal morphine given once
    Intervention Type
    Drug
    Intervention Name(s)
    intra thecal morphine
    Other Intervention Name(s)
    intra spinal morphine
    Intervention Description
    300 mcg intrathecal morphine given once
    Primary Outcome Measure Information:
    Title
    pain
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    nausea and vomiting
    Time Frame
    24 hours
    Title
    pruritus
    Time Frame
    24 hours
    Title
    sedation
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients for elective total knee arthroplasty Exclusion Criteria: No contraindication to spinal No allergy to morphine, rescue analgesia or anti-emesis treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick D Hassett, MD
    Organizational Affiliation
    Department of Anaesthesia, UCHG
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Laffey, MD
    Organizational Affiliation
    Department of Anaesthesia,UCHG
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Brian Kinirons, MD
    Organizational Affiliation
    Dept of Anaesthesia , UCHG
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18816386
    Citation
    Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
    Results Reference
    derived

    Learn more about this trial

    Intrathecal Morphine in Knee Arthroplasty

    We'll reach out to this number within 24 hrs