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NCT03695640 Clinical Trial

Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03695640
Other study ID # MgTKA
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2018
Est. completion date December 15, 2018

Study information
Verified date October 2018
Source Ufuk University
Contact Baturay K Kazbek, MD
Phone +903122044000
Email bkkazbek@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 15, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium Sulfate
Addition of magnesium sulfate as an adjuvant to levobupivacaine
Procedure:
• continuous femoral nerve block
continuous nerve block with levobupivacaine for treatment postoperative pain

Locations
Country Name City State
Turkey Ufuk University Faculty of Medicine Hospital Ankara Balgat

Sponsors (1)
Lead Sponsor Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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