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NCT Number: NCT06520475

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

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

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

genicular nerve block using bupivacaine and magnesium

Procedure

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

genicular nerve block using bupivacaine and normal saline

Procedure

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

Primary outcomes

  1. Numerical Rating Scale

    Time frame: 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 outcomes

  1. First request for analgesia

    Time frame: 24 hours post-operatively

  2. Total opioid consumption

    Time frame: 24 hours post-operatively

  3. Patient satisfaction

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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