- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695640
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 Contact
- Name: Baturay K Kazbek, MD
- Phone Number: 4098 +903122044000
- Email: bkkazbek@gmail.com
Study Locations
-
-
Balgat
-
Ankara, Balgat, Turkey, 06510
- Recruiting
- Ufuk University Faculty of Medicine Hospital
-
Contact:
- Baturay K Kazbek, MD
- Phone Number: 4098 +903122044000
- Email: bkkazbek@gmail.com
-
-
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
|
continuous nerve block with levobupivacaine for treatment postoperative pain
|
EXPERIMENTAL: Group LM
continuous femoral nerve block with levobupivacaine and magnesium sulfate
|
continuous nerve block with levobupivacaine for treatment postoperative pain
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
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.
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
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
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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