Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

NCT ID: NCT03695640

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2018-12-15

Brief Summary

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This study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty.

Detailed Description

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Pain after knee arthroplasty is a serious concern. This study was designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block on analgesic requirements following total knee arthroplasty.

Conditions

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Knee Arthroplasty, Total Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, controlled, prospective
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group L

continuous femoral nerve block with levobupivacaine

Group Type ACTIVE_COMPARATOR

continuous femoral nerve block

Intervention Type PROCEDURE

continuous nerve block with levobupivacaine for treatment postoperative pain

Group LM

continuous femoral nerve block with levobupivacaine and magnesium sulfate

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Addition of magnesium sulfate as an adjuvant to levobupivacaine

continuous femoral nerve block

Intervention Type PROCEDURE

continuous nerve block with levobupivacaine for treatment postoperative pain

Interventions

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Magnesium Sulfate

Addition of magnesium sulfate as an adjuvant to levobupivacaine

Intervention Type DRUG

continuous femoral nerve block

continuous nerve block with levobupivacaine for treatment postoperative pain

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* scheduled for elective unilateral primary total knee arthroplasty

Exclusion Criteria

* Patient refusal to enroll in the study
* Patient refusal of neuraxial anesthesia
* Existence of contraindications for neuraxial anesthesia
* Known history of allergy to any of the study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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Baturay Kansu Kazbek

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baturay K Kazbek, MD

Role: PRINCIPAL_INVESTIGATOR

Ufuk University

Locations

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Ufuk University Faculty of Medicine Hospital

Ankara, Balgat, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Baturay K Kazbek, MD

Role: CONTACT

+903122044000 ext. 4098

Facility Contacts

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Baturay K Kazbek, MD

Role: primary

+903122044000 ext. 4098

References

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Albrecht E, Morfey D, Chan V, Gandhi R, Koshkin A, Chin KJ, Robinson S, Frascarolo P, Brull R. Single-injection or continuous femoral nerve block for total knee arthroplasty? Clin Orthop Relat Res. 2014 May;472(5):1384-93. doi: 10.1007/s11999-013-3192-3.

Reference Type BACKGROUND
PMID: 23928707 (View on PubMed)

Other Identifiers

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MgTKA

Identifier Type: -

Identifier Source: org_study_id

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