Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block

Phase 3

Not yet recruiting

• Conditions: Post Operative Pain
• Interventions: Procedure: genicular nerve block using bupivacaine and normal saline; Procedure: genicular nerve block using bupivacaine and magnesium

• Registration Number: NCT06520475
• Lead Sponsor: Cairo University

Brief Summary

It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .

No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-25
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Study Start: 2024-08
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• American Society of Anesthesiologist (ASA) I or II physical status.
• Between 18 and 70 years of age.
• Both genders.
• Patients undergoing total knee replacement surgery.

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Exclusion Criteria

• Patient refusal.
• ASA Ⅲ and Ⅳ patients.
• Known allergy to the study drugs.
• Hypermagnesemia.
• Central or peripheral neurological disease.
• Pregnancy.
• Drug or alcohol abuse.
• Localized infection at the site of the block.
• Bleeding disorder (platelets count less than 100,000 or international normalized ratio more than 1.4)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine + Normal saline	genicular nerve block using bupivacaine and normal saline	-
Bupivacaine + Magnesium	genicular nerve block using bupivacaine and magnesium	-

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale	24 hours post-operatively	Pain will be assessed with Numerical Rating Scale. Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	24 hours post-operatively	Patient satisfaction will be assessed at 48 h postoperatively (0 = very dissatisfied, 2 = somewhat dissatisfied, 3 = somewhat satisfied, 4 = very satisfied)
First request for analgesia	24 hours post-operatively
Total opioid consumption	24 hours post-operatively