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Hyperalgesia and NMDA Receptor Antagonist

Primary Purpose

Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium Sulfate
ketamine
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA1-2

Exclusion Criteria:

  • contraindication to the study drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    magnesium

    ketamine

    control

    Arm Description

    magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries.

    ketamine is administered to those patients undergoing stated TKA and other operations.

    normal saline (placebo) is administered to the patients.

    Outcomes

    Primary Outcome Measures

    pain
    pain (QST and pain measures )until 1 month from the end of the operation

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2014
    Last Updated
    March 12, 2014
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02087202
    Brief Title
    Hyperalgesia and NMDA Receptor Antagonist
    Official Title
    Hyperalgesia and NMDA Receptor Antagonist
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    July 2014 (Anticipated)
    Study Completion Date
    July 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    NMDA receptor is administered and postoperative remote hyperalgesia is investigated.
    Detailed Description
    NMDA receptor is adminstered and postoperative tertiary hyperalgesia is investigated. QST and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain
    Keywords
    pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    magnesium
    Arm Type
    Experimental
    Arm Description
    magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries.
    Arm Title
    ketamine
    Arm Type
    Experimental
    Arm Description
    ketamine is administered to those patients undergoing stated TKA and other operations.
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    normal saline (placebo) is administered to the patients.
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium Sulfate
    Intervention Description
    magnesium sulfate is added to the patients
    Intervention Type
    Drug
    Intervention Name(s)
    ketamine
    Intervention Description
    ketamine is added to the patients.
    Primary Outcome Measure Information:
    Title
    pain
    Description
    pain (QST and pain measures )until 1 month from the end of the operation
    Time Frame
    until 1 month from the end of the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA1-2 Exclusion Criteria: contraindication to the study drugs

    12. IPD Sharing Statement

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