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Magnesium Sulfate

Clinical trials investigating Magnesium Sulfate are studying how it may help in different patient groups, including people having knee or breast surgery, women after cesarean section, and patients with preterm premature rupture of membranes. These trials mainly look at pain relief, pregnancy outcomes, and safety.

Table of Contents

Clinical trials overview

The source data shows several interventional studies of Magnesium Sulfate, which means researchers give the study treatment and then measure the results in people.[1][2] These trials are being done in different patient groups, including surgery patients, pregnant women, and women after childbirth.[2][3]

The trials are mainly in Phase 2 and Phase 3, which are stages used to test whether a treatment works and to keep checking safety in larger groups.[1][4] All listed studies are marked Authorised in the source data.[1]

Pain control studies after surgery

Two trials focus on pain after surgery and test Magnesium Sulfate as part of nerve block or pain relief care.[1][2] One Phase 3 study in total knee arthroplasty compares Magnesium Sulfate with other injected study treatments and measures the time until the patient first asks for rescue pain medicine.[1] Total knee arthroplasty means knee replacement surgery.[1]

Another Phase 3 study in breast cancer patients having mastectomy asks whether Magnesium Sulfate can provide pain relief similar to dexmedetomidine when used with ropivacaine in an erector spinae plane block.[2] The main outcome is the time from recovery from general anesthesia to the first request for rescue analgesia.[2] General anesthesia means sleep-like medicine used during surgery.[2]

A separate Phase 2 study in newly delivered women looks at whether adding intravenous Magnesium Sulfate after cesarean section improves acute postoperative pain within 6 hours.[4] This trial is randomized controlled, which means people are assigned to treatment groups by chance to compare results fairly.[4]

Pregnancy-related studies

One Phase 3 trial studies women with preterm premature rupture of membranes, which means the water around the baby breaks too early before labor starts.[3] The study tests a tailored treatment plan that includes Magnesium Sulfate along with antibiotics and steroids, with the goal of safely prolonging pregnancy.[3]

The main endpoint in this trial is whether pregnancy lasts more than 7 days from membrane rupture to delivery, which is called latency of pregnancy.[3] This outcome helps show whether the treatment can delay delivery for a meaningful time.[3]

Safety and outcome measures

Safety is an important part of the long-term extension trial in the source data, although that study is about GTX-102 and not Magnesium Sulfate.[1] For the Magnesium Sulfate trials, the main outcomes are mostly about how long pain relief lasts, when rescue pain medicine is needed, and whether pregnancy can be prolonged.[1][2][3][4]

In the knee surgery study, the key measure is the time in minutes from the adductor canal block until the first request for rescue analgesia.[1] In the mastectomy study, the key measure is the time from recovery from general anesthesia until the first request for rescue analgesia.[2] In the cesarean section study, the key measure is pain within 6 hours after surgery.[4]

Who may take part

The source data identifies different patient groups for each trial, so eligibility depends on the condition being studied.[1][2][3][4] The studies include people having total knee arthroplasty, women having mastectomy for breast cancer, pregnant women with preterm premature rupture of membranes, and newly delivered women after cesarean section.[1][2][3][4]

Enrollment is different across studies, with planned numbers of 131, 62, 138, and 150 participants in the trials listed here.[1][2][3][4] This shows that some studies are small and focused, while others include larger groups.

Trial phases and study design

Three trials are in Phase 3, including the knee surgery, mastectomy, and pregnancy studies.[1][2][3] One trial is in Phase 2, the study of postoperative pain after cesarean section.[4]

All four Magnesium Sulfate studies are interventional, so the treatment is actively given and then measured against the study outcome.[1][2][3][4] The trials use different routes such as injection, perineural use, and intravenous infusion, depending on the study question.[1][2][3][4]

Trial IDPhaseCondition studiedStatusEnrollment
2024-518601-17-00Phase 3Total knee arthroplastyAuthorised131
2025-523152-31-00Phase 3Breast cancerAuthorised62
2024-520237-77-00Phase 3Preterm premature rupture of membrance in pregnancyAuthorised138
2024-519617-56-00Phase 2Postoperative painAuthorised150

FAQ

  • What is being studied in Magnesium Sulfate trials? These trials study whether Magnesium Sulfate can improve pain control, support anesthesia blocks, or help pregnancy outcomes in specific groups. Some trials also measure safety and how long the effect lasts.
  • Who can take part in these trials? The target groups include people with total knee arthroplasty, women having mastectomy, pregnant women with preterm premature rupture of membranes, and newly delivered women after cesarean section. Each trial has its own rules for who can join.
  • What phases are the Magnesium Sulfate trials in? The trials in the source data are in Phase 2 and Phase 3. These phases usually test whether a treatment works and continue checking safety.
  • What outcomes are being measured? The trials measure things like time until the first rescue pain medicine is needed, acute postoperative pain within 6 hours, and pregnancy lasting more than 7 days after membrane rupture. One trial also tracks treatment-emergent side effects and serious side effects.
  • Are all Magnesium Sulfate trials studying the same condition? No. The trials cover different conditions, including postoperative pain, total knee arthroplasty, breast surgery, and preterm premature rupture of membranes. This means the same substance is being tested in different clinical settings.

Ongoing Clinical Trials on Magnesium Sulfate

  • Comparing magnesium sulfate and dexmedetomidine combined with ropivacaine for pain relief after breast cancer surgery in women undergoing mastectomy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Betamethasone Sodium Phosphate and Drug Combination for Pregnant Women with Preterm Premature Rupture of Membranes

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

  • Study on the Long-Term Safety of GTX-102 for Patients with Angelman Syndrome

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study on Magnesium Sulfate for Reducing Postoperative Pain in Women After Cesarean Section

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Sweden

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

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, helpful, or both.
  • Interventional study: A study where researchers give a treatment or procedure and then measure the results.
  • Phase 2: An early phase that usually looks at whether a treatment works and continues safety testing.
  • Phase 3: A later phase that compares treatments in larger groups of people to confirm benefits and safety.
  • Primary outcome: The main result the study is designed to measure.
  • Rescue analgesia: Extra pain medicine given when the first pain treatment is not enough.
  • Adductor canal block: A nerve block used to reduce pain after knee surgery.
  • Erector spinae plane block: A type of nerve block used to help control pain during or after surgery.
  • Preterm premature rupture of membranes: When the water around the baby breaks too early before labor starts.
  • Latency of pregnancy: The time between membrane rupture and delivery.
  • Treatment-emergent adverse events: Health problems that start or get worse after a person begins the study treatment.
  • Serious adverse events: Severe health problems that may need urgent medical care or hospital treatment.

References

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