Phase III Randomized, Double-Blind Trial Evaluating Perineural Magnesium Sulfate and Ropivacaine Hydrochloride in Total Knee Arthroplasty Analgesia

The primary objective of this Phase III randomized, double-blind clinical trial is to evaluate the **efficacy** of perineural **magnesium sulfate** in prolonging analgesia when used as an adjuvant to the local anesthetic **ropivacaine** in patients undergoing total knee arthroplasty. This is clinically relevant as effective pain management is crucial in enhancing postoperative recovery and patient satisfaction following knee replacement surgery. The trial aims to determine whether the addition of magnesium sulfate can extend the duration of nerve block, potentially reducing the need for additional analgesics and improving overall pain control.

The clinical trial focuses on patients undergoing **total knee arthroplasty** due to gonarthrosis. The study population includes both male and female participants, aged between 18 and 80 years, classified as ASA I, II, and III, indicating a range from healthy individuals to those with mild systemic disease. Participants were selected based on their scheduled surgery for total knee arthroplasty and their ability to provide informed consent. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is a **Phase III randomized, double-blind, controlled study** designed to evaluate the efficacy of **magnesium sulfate** as an adjuvant to **ropivacaine hydrochloride** in prolonging analgesia during total knee arthroplasty. The trial aims to determine the time elapsed from the administration of the adductor canal block until the first request for rescue analgesia. The study is expected to run from February 24, 2022, to July 31, 2025, with participants involved for a maximum treatment period of one day.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age (18-80 years), scheduled total knee arthroplasty due to gonarthrosis, and ASA classification I, II, or III. Informed consent must be obtained prior to participation. Following the screening, participants will be randomized to receive either the test drug, **magnesium sulfate**, or a placebo, both administered via injection. The trial includes follow-up visits to monitor the efficacy and safety of the treatment, with the primary endpoint being the duration of analgesia.

The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted. Participants may be withdrawn from the study if they experience adverse reactions, fail to comply with the study protocol, or withdraw consent. The trial is structured to ensure rigorous data collection and analysis, maintaining the integrity of the double-blind design to minimize bias and ensure reliable results.

The clinical trial involves the administration of **MAGNESIUM SULFATE**, which is utilized as an experimental medication. This compound is provided in the form of a solution for injection. The maximum daily dose is 6 grams, with a total dose not exceeding 6 grams over the treatment period. The administration route is via injection, and the treatment duration is limited to one day. **MAGNESIUM SULFATE** is employed to evaluate its efficacy in prolonging analgesia when used as an adjuvant to the local anesthetic in total knee arthroplasty.

**ROPIVACAINE HYDROCHLORIDE** serves as the local anesthetic in this study. It is also provided as a solution for injection. The maximum daily dose is 300 milligrams, with a total dose not exceeding 300 milligrams over the treatment period. The administration is conducted through injection, and the treatment period is restricted to one day. **ROPIVACAINE HYDROCHLORIDE** is used in conjunction with **MAGNESIUM SULFATE** to assess the potential enhancement of analgesic effects in the clinical setting.

**SALINE** is utilized as a non-experimental treatment in this trial, serving as a solvent and vehicle for compatible drugs that require parenteral administration. It is provided as a solution for injection, with a maximum daily dose of 100 grams and a total dose not exceeding 1000 grams over the treatment period. The administration route is injection, and the treatment duration is limited to one day. **SALINE** acts as a placebo in the study, ensuring the blinding of participants and maintaining the integrity of the trial's double-blind design.

The efficacy of the clinical trial will be assessed by evaluating the primary endpoint, which is the time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia. This endpoint is designed to measure the prolongation of analgesia provided by **magnesium sulfate** when used as an adjuvant to the local anesthetic **ropivacaine hydrochloride** in patients undergoing total knee arthroplasty. The trial is a Phase III randomized, double-blind study, aiming to confirm the safety and efficacy of the treatment. The efficacy parameters will be collected and analyzed at specified timepoints, ensuring a rigorous assessment of the treatment's impact on analgesia duration. The trial is structured to provide objective data on the potential benefits of adding magnesium sulfate to the anesthetic regimen in this surgical context.