Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty

June 2, 2024 updated by: Chang Gung Memorial Hospital
Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty

Exclusion Criteria:

  • hypersensitivity to magnesium sulfate
  • hypermagnesemia
  • severe cardiac, hepatic or renal compromised

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cocktail injection with Magnesium Sulfate
Cocktail injection with Marcaine, Dexamethasone, normal saline and Magnesium Sulfate
Drug: Magnesium sulfate
adding 300mg magnesium sulfate into cocktail injection
No Intervention: Cocktail injection without Magnesium Sulfate
Cocktail injection with Marcaine, Dexamethasone, and normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS score
Time Frame: day 0, day 1, day 2, day 3, day 7
day 0, day 1, day 2, day 3, day 7
muscle power
Time Frame: day 0, day 1, day 2, day 3
day 0, day 1, day 2, day 3
Straight leg raised test
Time Frame: day 0, day 1, day 2, day 3
day 0, day 1, day 2, day 3
active range of motion
Time Frame: day 0, day 1, day 2, day 3
day 0, day 1, day 2, day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Magnesium level in blood
Time Frame: day 0, day 1
day 0, day 1
Calcium level in blood
Time Frame: day 0, day 1
day 0, day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

June 2, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400399A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Magnesium sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe