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NCT01945437 Clinical Trial

Magnesium and TKA Pain

Pain Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01945437
Other study ID # Mg_TKA
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 13, 2013
Last updated September 13, 2013
Start date January 2014

Study information
Verified date September 2013
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium Sulfate
The magnesium group receive intravenous magnesium sulfate.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Pain measured with visual analogue scale (VAS) from the end of the TKA until 48 hour No
Secondary analgesic analgesic consumptions from the end of the TKA until 48 hours from the end of the TKA until 48 hours No
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