Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

Study Overview
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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.

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

Conditions
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Knee Arthroplasty, Total, Postoperative Pain

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Procedure: continuous femoral nerve block


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled, prospective
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L<br>continuous femoral nerve block with levobupivacaine | Procedure: continuous femoral nerve block<br>* continuous nerve block with levobupivacaine for treatment postoperative pain<br>|
| Experimental: Group LM<br>continuous femoral nerve block with levobupivacaine and magnesium sulfate | Drug: Magnesium Sulfate<br>* Addition of magnesium sulfate as an adjuvant to levobupivacaine<br>Procedure: continuous femoral nerve block<br>* continuous nerve block with levobupivacaine for treatment postoperative pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, continuous femoral nerve block, magnesium sulphate, postoperative pain