Magnesium and TKA Pain

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01945437
• Collaborator: (none)
• Enrollment: 60
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Magnesium Sulfate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Control group receive same volume of normal saline as in the magnesium group
Experimental: magnesium This group receive magnesium sulfate perioperatively.	Drug: Magnesium Sulfate; The magnesium group receive intravenous magnesium sulfate.

Outcome Measures

Primary Outcome Measures

1. Pain [from the end of the TKA until 48 hour]

   Pain measured with visual analogue scale (VAS)

Secondary Outcome Measures

1. analgesic [from the end of the TKA until 48 hours]

   analgesic consumptions from the end of the TKA until 48 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kim Mihyun, Doctor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT01945437
• Other Study ID Numbers: Mg_TKA
• First Posted: Sep 18, 2013
• Last Update Posted: Sep 18, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Magnesium Sulfate

Study Results

No Results Posted as of Sep 18, 2013