NCT01945437

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

September 13, 2013

Last Update Submit

September 13, 2013

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain measured with visual analogue scale (VAS)

    from the end of the TKA until 48 hour

Secondary Outcomes (1)

  • analgesic

    from the end of the TKA until 48 hours

Study Arms (2)

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

Magnesium SulfateDRUG

The magnesium group receive intravenous magnesium sulfate.

magnesium

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 13, 2013

First Posted

September 18, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Last Updated

September 18, 2013

Record last verified: 2013-09