Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

October 3, 2018 updated by: Baturay Kansu Kazbek, Ufuk University

The Effect of Magnesium Sulfate Added to Levobupivacaine in Continous Femoral Block on Analgesic Requirements Following Total Knee Arthroplasty

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Turkey
    • Balgat
      • Ankara, Balgat, Turkey, 06510
        • Recruiting
        • Ufuk University Faculty of Medicine Hospital
        • 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group L
continuous femoral nerve block with levobupivacaine
Procedure: continuous femoral nerve block
continuous nerve block with levobupivacaine for treatment postoperative pain
EXPERIMENTAL: Group LM
continuous femoral nerve block with levobupivacaine and magnesium sulfate
Procedure: continuous femoral nerve block
continuous nerve block with levobupivacaine for treatment postoperative pain
Drug: Magnesium Sulfate
Addition of magnesium sulfate as an adjuvant to levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score
Time Frame: T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours
measurement of postoperative pain using Visual Analogue Score. Minimum: 0 Maximum: 10. Higher values represent more pain, hence lower values are better
T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption
Time Frame: T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours
Consumption of local anesthetic in patient controlled analgesia
T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours

Collaborators and Investigators

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

Sponsor

Ufuk University

Investigators

  • Principal Investigator: Baturay K Kazbek, MD, UFUK UNIVERSITY FACULTY OF MEDICINE

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 (ANTICIPATED)

November 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 15, 2018

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (ACTUAL)

October 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MgTKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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