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Study on Magnesium Sulfate and Ropivacaine for Pain Relief in Knee Replacement Surgery Patients

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of magnesium sulfate in patients undergoing total knee replacement surgery. The trial aims to determine if magnesium sulfate can enhance the effectiveness of a nerve block, which is a type of anesthesia used to reduce pain during and after surgery. The nerve block is performed using ropivacaine hydrochloride, a local anesthetic that numbs the area around the knee. In this study, magnesium sulfate is used as an additional treatment to see if it can prolong the pain relief provided by the nerve block.

Participants in the study will receive an injection of either magnesium sulfate or a placebo along with ropivacaine hydrochloride during their knee surgery. The study will monitor how long it takes for patients to request additional pain relief after receiving the nerve block. This will help researchers understand if magnesium sulfate can effectively extend the duration of pain relief.

The purpose of this study is to evaluate the potential benefits of using magnesium sulfate as an adjuvant, or helper, to improve pain management in patients undergoing total knee replacement surgery. The trial is designed to provide valuable information on whether this combination can offer better pain control, which could lead to improved recovery experiences for patients undergoing this common surgical procedure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding and agreement to participate in the clinical trial.

  2. Step 2

    Preparation for surgery

    You will be scheduled for a total knee arthroplasty, which is a type of knee surgery. This is part of the study to evaluate pain management techniques.

  3. Step 3

    Receiving the nerve block

    Before the surgery, you will receive an adductor canal block. This is a type of anesthesia that helps reduce pain during and after the surgery.

    The block will include a local anesthetic called ropivacaine hydrochloride and may also include magnesium sulfate to see if it helps prolong pain relief.

  4. Step 4

    Monitoring pain relief

    After receiving the nerve block, the time will be recorded until you first request additional pain relief, known as rescue analgesia.

    This helps the study measure how effective the nerve block is in managing pain.

  5. Step 5

    Post-surgery follow-up

    Following your surgery, you will be monitored to assess your recovery and any side effects from the medications used.

    Regular follow-ups will be scheduled to ensure your well-being and to gather data for the study.

Who can join the trial?

4 criteria

  • Patients who are scheduled to have a total knee replacement surgery due to knee joint wear and tear (gonarthrosis).
  • Patients classified as ASA I, II, and III, which means they are in different categories of health status but are generally healthy enough for surgery. This includes both men and women.
  • Patients who are between 18 and 80 years old.
  • Patients who have signed an informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

  • Patients who are not undergoing total knee arthroplasty (a type of knee surgery) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population cannot participate.
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Investigated drugs

  • Magnesium Sulfate

    is being studied to see if it can help reduce pain after knee surgery. It is used in this trial as an additional medicine to help the main pain relief medicine work better and last longer. The researchers want to find out if adding magnesium sulfate can make the pain relief last longer after the surgery.

  • Ropivacaine

    is the main medicine used to numb the area around the knee during surgery. It helps to block pain signals from reaching the brain, so patients feel less pain during and after the surgery. In this trial, ropivacaine is used to see how well it works with magnesium sulfate to provide longer-lasting pain relief.

What is already known about the treatment

Magnesium Sulfate – Magnesium sulfate is administered as an injection near the nerves, specifically in the adductor canal, during knee replacement surgery. It is currently being studied in clinical trials to see if it can help extend the pain relief provided by another medication called ropivacaine. The main use being explored is to help manage pain after knee surgery. At the molecular level, magnesium sulfate is thought to work by blocking certain signals in the nervous system that are responsible for pain. It is classified as a mineral supplement and is being investigated for its potential benefits in pain management.

Investigated diseases

Total knee arthroplasty – Total knee arthroplasty is a surgical procedure that involves replacing the knee joint with artificial components. This procedure is typically performed to relieve pain and restore function in severely diseased knee joints, often due to osteoarthritis. The progression of the condition leading to this surgery involves the gradual wearing down of the cartilage in the knee joint, resulting in pain, stiffness, and decreased mobility. Over time, the joint may become deformed, and the pain can become severe, affecting daily activities. The surgery aims to alleviate these symptoms by replacing the damaged joint surfaces with prosthetic components. Recovery involves rehabilitation to regain strength and mobility in the knee.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518601-17-00Protocol codeFPS-SMG-2021-02Estimated enrolment131 patientsSponsorFundacion Progreso Y Salud

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