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Magnesium Sulfate

Questo articolo riassume i trial clinici su Magnesium Sulfate. Gli studi valutano soprattutto efficacia e sicurezza in diversi gruppi di pazienti, come persone sottoposte a chirurgia del ginocchio o del seno, donne dopo taglio cesareo e pazienti con rottura prematura delle membrane in gravidanza.

Table of contents

Overview of the studies

The source data includes four interventional trials studying Magnesium Sulfate in different clinical settings.[1] These studies are authorised and are mainly focused on pain control after surgery or on pregnancy prolongation in a specific obstetric condition.[1]

All four trials are designed to compare Magnesium Sulfate with other treatments or with standard care, depending on the study question.[1] The research is not about the substance itself as a general medicine; it is about whether it helps in the specific patient groups included in each trial.[1]

Who is being studied

One Phase 3 trial includes people having total knee arthroplasty, which is knee replacement surgery.[2] This study looks at whether perineural Magnesium Sulfate, meaning use around a nerve block, can improve pain relief when added to ropivacaine.[2]

Another Phase 3 trial includes patients with breast cancer who are undergoing mastectomy, a surgery to remove the breast.[3] In this study, Magnesium Sulfate is tested as an adjuvant, which means an added treatment, to compare it with dexmedetomidine for postoperative pain control.[3]

A third Phase 3 study includes pregnant patients with preterm premature rupture of membrance.[4] This condition means the water breaks too early in pregnancy, before labor begins, and the study tests whether tailored treatment can safely prolong pregnancy.[4]

The fourth trial includes newly delivered women after cesarean section and studies postoperative pain.[5] It evaluates whether adding intravenous Magnesium Sulfate can improve pain outcomes in the hours after surgery.[5]

What the trials are testing

In the knee surgery study, researchers are testing whether Magnesium Sulfate can prolong analgesia, which means extend pain relief, when used with ropivacaine in an adductor canal block.[2] The main question is how long it takes before the patient first asks for rescue pain medicine.[2]

In the mastectomy study, the main question is whether Magnesium Sulfate offers an analgesic profile comparable to dexmedetomidine when added to 0.3% ropivacaine in an erector spinae plane block.[3] The study compares the time from recovery from general anesthesia to the first request for rescue analgesia.[3]

In the pregnancy study, the aim is to see whether tailored antibiotic and steroid therapy based on IL-6 in amniotic fluid is linked to longer pregnancy compared with standard treatment.[4] Magnesium Sulfate is one of the listed interventions in that treatment plan.[4]

In the cesarean section study, the goal is to find out whether adding intravenous Magnesium Sulfate improves acute postoperative pain during the first 6 hours after surgery.[5] This is a practical question for early recovery after delivery.[5]

Trial phases and sizes

The source data shows two broad phases of development: Phase 2 and Phase 3.[2][3][4][5] Phase 2 is usually an earlier step in testing, while Phase 3 is a later and larger step that gives more information about benefit and safety.[5]

The planned enrollment ranges from 62 participants to 150 participants across the four trials.[2][3][4][5] The largest study listed is the postoperative pain trial in newly delivered women, with 150 participants.[5]

Main outcomes being measured

The knee surgery trial measures the time, in minutes, from the adductor canal block to the first request for rescue analgesia.[2] A longer time suggests longer pain relief after the block.[2]

The mastectomy trial measures the time in minutes between recovery from general anesthesia and the first request for rescue analgesia.[3] This helps show how long postoperative pain relief lasts after surgery.[3]

The pregnancy trial uses a different main endpoint: pregnancy latency of more than 7 days from premature rupture of membranes to delivery.[4] This endpoint checks whether the treatment can safely delay birth for at least one week.[4]

The cesarean section trial measures acute postoperative pain within 6 hours.[5] This is important because early pain control can affect comfort and recovery after delivery.[5]

Safety information in the trials

Only one study in the source data gives a detailed safety endpoint for Magnesium Sulfate.[1] That long-term extension study in Angelman syndrome tracks treatment-emergent adverse events and serious adverse events, including their frequency, severity, and relationship to the investigational product throughout the study.[1]

For the Magnesium Sulfate studies in surgery and pregnancy, the source data mainly highlights effectiveness endpoints rather than detailed safety measures.[2][3][4][5] This means the trials are primarily designed to answer whether the treatment helps in the studied setting, while safety is still part of the overall trial review.[2][3][4][5]

Trial summary by study

The table below gives a simple overview of the trials that include Magnesium Sulfate in the source data.[1][2][3][4][5]

Trial ID Title Phase Condition Status Enrollment Main endpoint
2024-518601-17-00 Clinical trial Phase III to study whether magnesium sulfate improves nerve block in knee surgeries. Phase 3 Total knee arthroplasty Authorised 131 Time from adductor canal block to first rescue analgesia request
2025-523152-31-00 Is magnesium sulfate an alternative with an analgesic and safety profile equivalent to dexmedetomidine as an adjuvant to ropivacaine in erector block in mastectomy? Phase 3 Breast cancer Authorised 62 Time from recovery from general anesthesia to first rescue analgesia request
2024-520237-77-00 TAILORED-PROM: Personalized therapeutic approach for preterm premature rupture of membranes to safely prolong pregnancy, enhance maternal and neonatal outcomes, and minimize unnecessary antibiotic use. Phase 3 Preterm premature rupture of membrance in pregnancy Authorised 138 Pregnancy latency of more than 7 days
2024-519617-56-00 Magnesiumsulphate for Postoperative Analgesia In the Newly delivered, The MAG-PAIN randomized controlled trial. Phase 2 Postoperative pain Authorised 150 Acute postoperative pain within 6 hours
Trial ID Phase Condition studied Status Enrollment
2024-518601-17-00 Phase 3 Total knee arthroplasty Authorised 131
2025-523152-31-00 Phase 3 Breast cancer Authorised 62
2024-520237-77-00 Phase 3 Preterm premature rupture of membrance in pregnancy Authorised 138
2024-519617-56-00 Phase 2 Postoperative pain Authorised 150

FAQ

  • Who is being studied in the Magnesium Sulfate trials? The trials include adults having total knee arthroplasty, patients undergoing mastectomy, pregnant women with preterm premature rupture of membranes, and newly delivered women after cesarean section.
  • What are the main goals of these trials? The main goals are to see whether Magnesium Sulfate improves pain relief, delays the need for rescue pain medicine, or helps prolong pregnancy in selected patients.
  • What phase are the Magnesium Sulfate trials in? The source data includes Phase 2 and Phase 3 studies. These later-phase trials are used to test how well the treatment works and to collect more safety information.
  • What conditions are being studied? The trials study total knee arthroplasty, breast cancer surgery, preterm premature rupture of membranes in pregnancy, and postoperative pain after cesarean section.
  • What outcomes are the trials measuring? The studies measure time to first rescue analgesia, acute postoperative pain within 6 hours, and pregnancy latency of more than 7 days in one trial. One trial also tracks treatment-emergent adverse events and serious adverse events.

Sperimentazioni cliniche in corso su Magnesium Sulfate

  • Studio sul solfato di magnesio e dexmedetomidina come adiuvanti alla ropivacaina nel blocco del muscolo erettore spinale per pazienti con tumore al seno

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

  • Studio clinico su rottura prematura delle membrane: valutazione di betametasone sodio fosfato e combinazione di farmaci per prolungare la gravidanza in donne incinte

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Cechia

  • Studio sull’Efficacia e Sicurezza a Lungo Termine di GTX-102 nei Pazienti con Sindrome di Angelman

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia Germania Spagna

  • Studio sull’uso del solfato di magnesio per ridurre il dolore post-operatorio nelle donne dopo il parto cesareo

    Arruolamento non iniziato

    1 1 1
    Farmaci in studio:
    Svezia

  • Studio sull’efficacia del solfato di magnesio e ropivacaina cloridrato nel blocco nervoso per pazienti sottoposti ad artroplastica totale del ginocchio

    Arruolamento non iniziato

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

Glossario

  • Clinical trial: A planned research study in people. It is used to test whether a treatment is safe, works well, or both.
  • Interventional study: A study where researchers give a treatment or compare treatments and then watch what happens.
  • Phase 2: A mid-stage clinical trial. It usually looks at early signs that a treatment works and continues to check safety.
  • Phase 3: A later-stage clinical trial. It compares treatments in larger groups and gives stronger evidence about benefit and safety.
  • Enrollment: The number of people planned to take part in the study.
  • Primary outcome: The main result the researchers want to measure. It is the most important answer the trial is trying to find.
  • Rescue analgesia: Extra pain medicine given if the first treatment does not control pain well enough.
  • Postoperative pain: Pain after surgery.
  • Adductor canal block: A type of nerve block used around the knee to help reduce pain after surgery.
  • Erector spinae plane block: A nerve block technique used to help control pain after surgery, especially in chest surgery.
  • Preterm premature rupture of membranes: When the water breaks too early in pregnancy, before labor starts and before 37 weeks.
  • Latency of pregnancy: The time between membrane rupture and delivery. In this study, the key target is more than 7 days.

Riferimenti

  1. https://clinicaltrials.gov/study/2024-510917-14-00
  2. https://clinicaltrials.gov/study/2024-518601-17-00
  3. https://clinicaltrials.gov/study/2025-523152-31-00
  4. https://clinicaltrials.gov/study/2024-520237-77-00
  5. https://clinicaltrials.gov/study/2024-519617-56-00