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

NCT ID: NCT06520475

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-10-07

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

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine + Magnesium

Group Type: ACTIVE_COMPARATOR

genicular nerve block using bupivacaine and magnesium

Intervention Type: PROCEDURE

The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of 10% magnesium sulfate

Bupivacaine + Normal saline

Group Type: PLACEBO_COMPARATOR

genicular nerve block using bupivacaine and normal saline

Intervention Type: PROCEDURE

The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of normal saline

Interventions

genicular nerve block using bupivacaine and magnesium

The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of 10% magnesium sulfate

Intervention Type: PROCEDURE

genicular nerve block using bupivacaine and normal saline

The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of normal saline

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alaini hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-157-2024

Identifier Type: -

Identifier Source: org_study_id