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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06520475
Enrollment
94
Registered
2024-07-25
Start date
2024-08-01
Completion date
2025-10-07
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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

Interventions

PROCEDUREgenicular nerve block using bupivacaine and magnesium

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

PROCEDUREgenicular nerve block using bupivacaine and normal saline

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scale24 hours post-operativelyPain 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

MeasureTime frameDescription
First request for analgesia24 hours post-operatively
Total opioid consumption24 hours post-operatively
Patient satisfaction24 hours post-operativelyPatient satisfaction will be assessed at 48 h postoperatively (0 = very dissatisfied, 2 = somewhat dissatisfied, 3 = somewhat satisfied, 4 = very satisfied)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026