Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block
1 other identifier
interventional
94
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2024
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2024
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2025
CompletedNovember 17, 2025
July 1, 2024
1.1 years
July 21, 2024
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
First request for analgesia
24 hours post-operatively
Total opioid consumption
24 hours post-operatively
Patient satisfaction
24 hours post-operatively
Study Arms (2)
Bupivacaine + Magnesium
ACTIVE COMPARATORBupivacaine + Normal saline
PLACEBO COMPARATORInterventions
The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of 10% magnesium sulfate
The patients will receive 13 ml of 0.5% bupivacaine and 2 ml of normal saline
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alaini hospital
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anaesthesia
Study Record Dates
First Submitted
July 21, 2024
First Posted
July 25, 2024
Study Start
August 1, 2024
Primary Completion
September 15, 2025
Study Completion
October 7, 2025
Last Updated
November 17, 2025
Record last verified: 2024-07