Hyperalgesia and NMDA Receptor Antagonist
Primary Purpose
Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium Sulfate
ketamine
Sponsored by
About this trial
This is an interventional prevention trial for Pain focused on measuring pain
Eligibility Criteria
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
NCT ID
NCT02087202
First Posted
March 12, 2014
Last Updated
March 12, 2014
Sponsor
Seoul National University Bundang Hospital
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
Learn more about this trial
Hyperalgesia and NMDA Receptor Antagonist
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