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

Verified siteRegistered 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 adding magnesium sulfate to the treatment plan for women who have just delivered a baby via cesarean section. The main goal is to see if this addition can help improve pain relief after surgery. Magnesium sulfate is a substance that can be given through an IV infusion, which means it is delivered directly into the bloodstream through a vein. This study will compare the effects of magnesium sulfate with a placebo to understand its impact on reducing postoperative pain.

The study will involve women who have undergone a cesarean section and will monitor their pain levels at different times after the surgery. The researchers will look at how well the pain is managed within the first six hours, as well as after 24 hours, 14 days, and even up to three months. They will also assess other factors like the use of pain medications, the occurrence of nausea and vomiting, and the quality of breastfeeding and bonding with the baby.

Participants in the study will receive either magnesium sulfate or a placebo through an IV infusion. The study aims to provide valuable information on whether magnesium sulfate can be an effective addition to pain management strategies for women recovering from a cesarean section. The findings could help improve recovery experiences and outcomes for new mothers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be adults over 18, undergoing a cesarean section under spinal anesthesia, and able to understand information in Swedish.
Step 2
Administration of medication
The study involves the administration of magnesium sulfate through an intravenous infusion. This is done to assess its effect on postoperative pain management.
Step 3
Monitoring acute postoperative pain
Acute postoperative pain is monitored within the first 6 hours after the cesarean section. This helps in evaluating the immediate effects of the treatment.
Step 4
Follow-up on pain and recovery
Pain levels are assessed at various intervals: after 24 hours, 14 days, and 3 months. This includes both rest and movement scenarios.
Early recovery is evaluated after 24 hours and 14 days to understand the recovery process.
Step 5
Evaluation of additional outcomes
Opioid consumption is measured by the total dose of intravenous morphine equivalents used within 24 hours.
Postoperative nausea and vomiting are assessed, focusing on the highest intensity experienced within 24 hours.
Step 6
Assessment of breastfeeding and connection
Participants self-evaluate the quality of breastfeeding and connection with the newborn. Scores are compared between groups after 24 hours and 14 days, with a scale from 0 to 10.

Who can join the trial?

4 criteria

Must be an adult over the age of 18.
Must be a woman undergoing a cesarean section, which is a surgical procedure to deliver a baby.
The cesarean section must be performed under spinal anesthesia, which is a type of anesthesia that numbs the lower part of the body.
Must be able to understand and process information in Swedish.

Who cannot join the trial?

5 criteria

Individuals who are not pregnant women cannot participate.
Men are not eligible to join the study.
Participants must be within a specific age range, typically adults.
People with certain health conditions that might interfere with the study may be excluded.
Participants who are part of a vulnerable population, which means they might need special protection, may not be eligible.

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Verified
Region Halland
Varberg, Sweden

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Investigated drugs

Magnesium Sulfate is being studied to see if it can help reduce pain after a cesarean section. It is given through an IV to women who have just delivered a baby. The goal is to find out if it can make recovery more comfortable by lessening the pain experienced after the surgery.

Magnesium Sulfate

What is already known about the treatment

Magnesium Sulfate – This medication is administered intravenously, meaning it is given directly into a vein. Currently, it is being studied in clinical trials for its potential to improve postoperative pain management, particularly in women who have undergone a cesarean section. Magnesium sulfate is primarily used to relieve pain after surgery. It works by blocking certain receptors in the nervous system, which can help reduce the sensation of pain. Pharmacologically, it is classified as a mineral supplement and is known for its role in various bodily functions, including nerve and muscle function.

Investigated diseases

Postoperative Pain – This condition refers to the discomfort or pain experienced by patients following a surgical procedure. It typically begins immediately after surgery and can vary in intensity from mild to severe. The pain is often due to tissue damage and inflammation caused by the surgical incision. It can affect a patient's ability to move and perform daily activities, impacting their overall recovery process. The pain may persist for a few days to weeks, depending on the type of surgery and individual factors. Managing this pain effectively is crucial for promoting healing and improving the patient's quality of life.