Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

Phase 4

• Conditions: Knee Arthroplasty, Total; Postoperative Pain
• Interventions: Drug: Magnesium Sulfate; Procedure: continuous femoral nerve block

• Registration Number: NCT03695640
• Lead Sponsor: Ufuk University

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-04
• Last Update Posted: 2018-10-05
• Study Start: 2018-11-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group LM	continuous femoral nerve block	continuous femoral nerve block with levobupivacaine and magnesium sulfate
Group L	continuous femoral nerve block	continuous femoral nerve block with levobupivacaine
Group LM	Magnesium Sulfate	continuous femoral nerve block with levobupivacaine and magnesium sulfate

Primary Outcome Measures

Name	Time	Method
Visual Analogue Score	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

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption	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

Trial Locations

Locations (1)

Ufuk University Faculty of Medicine Hospital; 🇹🇷 Ankara, Balgat, Turkey