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
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total
• Pain, Postoperative
• Postoperative Pain

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