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Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

Primary Purpose

Knee Arthroplasty, Total, Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Magnesium Sulfate
continuous femoral nerve block
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroplasty, Total focused on measuring total knee arthroplasty, postoperative pain, continuous femoral nerve block, magnesium sulphate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ufuk University Faculty of Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group L

Group LM

Arm Description

continuous femoral nerve block with levobupivacaine

continuous femoral nerve block with levobupivacaine and magnesium sulfate

Outcomes

Primary Outcome Measures

Visual Analogue Score
measurement of postoperative pain using Visual Analogue Score. Minimum: 0 Maximum: 10. Higher values represent more pain, hence lower values are better

Secondary Outcome Measures

Analgesic consumption
Consumption of local anesthetic in patient controlled analgesia

Full Information

First Posted
October 2, 2018
Last Updated
October 3, 2018
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT03695640
Brief Title
Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty
Official Title
The Effect of Magnesium Sulfate Added to Levobupivacaine in Continous Femoral Block on Analgesic Requirements Following Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroplasty, Total, Postoperative Pain
Keywords
total knee arthroplasty, postoperative pain, continuous femoral nerve block, magnesium sulphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled, prospective
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Active Comparator
Arm Description
continuous femoral nerve block with levobupivacaine
Arm Title
Group LM
Arm Type
Experimental
Arm Description
continuous femoral nerve block with levobupivacaine and magnesium sulfate
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Addition of magnesium sulfate as an adjuvant to levobupivacaine
Intervention Type
Procedure
Intervention Name(s)
continuous femoral nerve block
Intervention Description
continuous nerve block with levobupivacaine for treatment postoperative pain
Primary Outcome Measure Information:
Title
Visual Analogue Score
Description
measurement of postoperative pain using Visual Analogue Score. Minimum: 0 Maximum: 10. Higher values represent more pain, hence lower values are better
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
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Consumption of local anesthetic in patient controlled analgesia
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baturay K Kazbek, MD
Phone
+903122044000
Ext
4098
Email
bkkazbek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baturay K Kazbek, MD
Organizational Affiliation
UFUK UNIVERSITY FACULTY OF MEDICINE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ufuk University Faculty of Medicine Hospital
City
Ankara
State/Province
Balgat
ZIP/Postal Code
06510
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baturay K Kazbek, MD
Phone
+903122044000
Ext
4098
Email
bkkazbek@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23928707
Citation
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.
Results Reference
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Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

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