In short
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.
Key points
- Clinical trials of Magnesium Sulfate are studying its use in pain control and pregnancy-related care. The source data includes Phase 2 and Phase 3 interventional studies. Target groups include people having knee surgery, women having mastectomy, pregnant women with preterm premature rupture of membranes, and newly delivered women after cesarean section. The main outcomes focus on how long pain relief lasts, when rescue pain medicine is first needed, and whether pregnancy can be prolonged. One trial also tracks treatment-emergent adverse events and serious adverse events.
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. These trials are being done in different patient groups, including surgery patients, pregnant women, and women after childbirth.
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. All listed studies are marked Authorised in the source data.
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. 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. Total knee arthroplasty means knee replacement surgery.
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. The main outcome is the time from recovery from general anesthesia to the first request for rescue analgesia. General anesthesia means sleep-like medicine used during surgery.
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. This trial is randomized controlled, which means people are assigned to treatment groups by chance to compare results fairly.
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. The study tests a tailored treatment plan that includes Magnesium Sulfate along with antibiotics and steroids, with the goal of safely prolonging pregnancy.
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. This outcome helps show whether the treatment can delay delivery for a meaningful time.
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. 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.
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. In the mastectomy study, the key measure is the time from recovery from general anesthesia until the first request for rescue analgesia. In the cesarean section study, the key measure is pain within 6 hours after surgery.
Who may take part
The source data identifies different patient groups for each trial, so eligibility depends on the condition being studied. 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.
Enrollment is different across studies, with planned numbers of 131, 62, 138, and 150 participants in the trials listed here. 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. One trial is in Phase 2, the study of postoperative pain after cesarean section.
All four Magnesium Sulfate studies are interventional, so the treatment is actively given and then measured against the study outcome. The trials use different routes such as injection, perineural use, and intravenous infusion, depending on the study question.