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

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What is this study about?

This study is looking at pain control after surgery for breast cancer. When a patient has a mastectomy, which is surgery to remove the breast, doctors use a nerve block to help reduce pain after the operation. A nerve block is when medicine is injected near the nerves to numb an area of the body. In this study, the main medicine used for the nerve block is ropivacaine, which is a local anesthetic that blocks pain signals. However, doctors can add other medicines to the ropivacaine to make the pain relief last longer. This study will compare two different medicines that can be added: magnesium sulfate and dexmedetomidine. Both of these medicines are thought to help the pain relief last longer when added to the nerve block.

The purpose of this study is to find out if magnesium sulfate works as well as dexmedetomidine when added to ropivacaine for pain control after mastectomy surgery. The study will measure how long the pain relief lasts by recording the time between when a patient wakes up from anesthesia and when they first ask for additional pain medicine. Patients in the study will receive general anesthesia for their surgery, and they will also receive a nerve block called an erector spinae plane block. This type of block is given by injecting the pain medicine near the muscles along the spine in the back. Some patients will receive ropivacaine with magnesium sulfate added, while others will receive ropivacaine with dexmedetomidine added.

During the study, doctors will watch how well the pain control works and check for any side effects. They will ask patients to rate their pain level at different times after surgery using a scale from zero to ten, where zero means no pain and ten means the worst pain imaginable. They will also keep track of how much additional pain medicine patients need in the first twenty-four hours after surgery. The study will monitor heart rate and blood pressure, and watch for side effects such as nausea, vomiting, slow heart rate, low blood pressure, breathing problems, itching, or any problems related to the nerve block itself. At the end, patients will be asked how satisfied they are with their pain control using a scale from zero to one hundred.

1 Receiving nerve block before surgery

Before the surgical procedure begins, you will receive an erector spinae plane block. This is a type of nerve block that numbs the area around the surgical site to help manage pain after surgery.

The block will contain ropivacaine, a local numbing medication at a concentration of 0.3%. This medication helps block pain signals from the nerves.

Additionally, one of two adjuvant medications will be added to the ropivacaine: either magnesium sulfate or dexmedetomidine. These medications are added to help the pain relief last longer.

The nerve block will be administered through an injection near the spine in the area of the surgery.

2 Undergoing mastectomy surgery

You will undergo the planned mastectomy surgery under general anesthesia. General anesthesia means you will be completely asleep during the procedure.

3 Recovery period immediately after surgery

After the surgery is completed, you will wake up from general anesthesia in the post-anesthesia care unit. This is a recovery area where medical staff monitor patients closely after surgery.

At the time of arrival in this recovery area, your pain level will be measured using a scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

Your heart rate and blood pressure will also be monitored.

4 Pain monitoring during the first 24 hours

Your pain level will be assessed at specific times: when you arrive in the recovery area, and then at 2 hours, 4 hours, 8 hours, 10 hours, and 24 hours after surgery.

The pain scale ranges from 0, which means no pain, to 10, which means the maximum pain you can imagine.

Your heart rate and blood pressure will continue to be monitored during this period.

Medical staff will observe you for any side effects such as nausea, vomiting, slow heart rate (less than 60 beats per minute), low blood pressure, difficulty breathing, itching, or any complications related to the nerve block.

5 Requesting additional pain medication if needed

If you experience pain that requires additional relief, you may request rescue analgesia. Rescue analgesia refers to extra pain medication given when the initial pain management is not sufficient.

The time between when you wake up from anesthesia and when you first request this additional pain medication will be recorded.

The total amount of rescue pain medication you receive during the first 24 hours after surgery will also be recorded.

6 Satisfaction assessment at 24 hours

At 24 hours after surgery, you will be asked to rate your satisfaction with the pain management you received.

The satisfaction scale ranges from 0 to 100 points, where 0 means you are very dissatisfied with the pain relief provided, and 100 means you are totally satisfied with the pain relief provided.

Who Can Join the Study?

  • You must be between 18 and 75 years old
  • You must be scheduled for elective mastectomy, which is a planned breast removal surgery that is not an emergency
  • The surgery must be performed under general anesthesia, which means you will be completely asleep during the procedure
  • You must be classified as ASA I-III, which is a rating system doctors use to assess your overall health status before surgery, ranging from healthy patients to those with controlled medical conditions
  • You must have no contraindications for locoregional anesthesia, which means there are no medical reasons that would make it unsafe for you to receive nerve block injections in a specific area of your body

Who Cannot Join the Study?

  • No exclusion criteria have been specified for this clinical trial in the available information.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hospital Universitario De La Plana Villarreal Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
15.12.2025

Trial locations

Magnesium sulfate is a mineral compound that is being tested in this study as an addition to pain-blocking medication during breast removal surgery. It is being used to help extend the time that patients remain pain-free after their operation.

Ropivacaine is a local anesthetic medication that numbs a specific area of the body by blocking pain signals from nerves. In this study, it is injected near the spine to prevent pain during and after breast surgery.

Dexmedetomidine is a sedative medication that can also help reduce pain and anxiety. In this study, it is being used as an addition to the pain-blocking medication and is being compared with magnesium sulfate to see which one works better at keeping patients comfortable after surgery.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where abnormal cells in the breast tissue grow and multiply in an uncontrolled manner. These cells can form lumps or masses called tumors that may be felt during examination or seen on imaging tests. The disease typically begins in the milk ducts or the lobules that produce milk. As the cancer progresses, it can spread to nearby lymph nodes and other parts of the body through the bloodstream or lymphatic system. The growth rate and pattern of spread varies depending on the type of breast cancer. Early stage breast cancer is confined to the breast or nearby lymph nodes, while advanced stages involve spread to distant organs.

Trial ID:
2025-523152-31-00
Protocol code:
MAGDEX-MAS
Trial Phase:
Therapeutic confirmatory (Phase III)

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