Magnesium and TKA Pain | NCT01945437

Studies
Magnesium and TKA Pain

NCT01945437

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Sep 18, 2013Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Magnesium Sulfate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Sep 13, 2013

First Submission Date that Met QC Criteria

Sep 13, 2013

First Posted Date

Sep 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2013

Last Update Posted Date

Sep 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kim Mihyun, Doctor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

The hypothesis of this study is that in staged bilateral total knee arthroplasty (TKA, magnesium sulfate administered during the perioperative period of the first TKA may decrease pain after the second TKA. It is known that pain is greater in the second TKA than in the first. Therefore, we compared pain of the second TKA between the magnesium and control groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Control group receive same volume of normal saline as in the magnesium group
magnesium	Experimental	This group receive magnesium sulfate perioperatively.	Drug: Magnesium Sulfate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug	The magnesium group receive intravenous magnesium sulfate.	magnesium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain measured with visual analogue scale (VAS)	from the end of the TKA until 48 hour

Secondary Outcomes

Measure	Description	Time Frame
analgesic	analgesic consumptions from the end of the TKA until 48 hours	from the end of the TKA until 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: American society of anesthesiologist physical status 1 - 2. patients scheduled to undergo staged bilateral TKA

Exclusion Criteria: American society of anesthesiologist physical status >3

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided