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

Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block in Total Knee Replacement Surgeries: a Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: genicular nerve block using bupivacaine and magnesium; Procedure: genicular nerve block using bupivacaine and normal saline

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine + Magnesium	Procedure: genicular nerve block using bupivacaine and magnesium; The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of 10% magnesium sulfate
Placebo Comparator: Bupivacaine + Normal saline	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	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.	24 hours post-operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): October 7, 2025

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Pharmaceutical Preparations; Inorganic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Elements; Metals, Light; Metals; Metals, Alkaline Earth; Saline Solution; Magnesium
• Other Study ID Numbers: N-157-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No