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

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

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
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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

5 criteria

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 trial?

1 criterion

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

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Investigated drugs

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.

What is already known about the treatment

Magnesium Sulfate
Magnesium sulfate is a mineral compound that can be administered through injection into the body, and in this study it is being used as an addition to local anesthetic medication during a nerve block procedure for breast surgery. It works by blocking certain receptors in the nervous system that transmit pain signals, which may help extend the pain-relieving effects of the anesthetic. This medication is already approved and commonly used in medicine for various purposes including treating seizures in pregnancy and preventing complications, but its use as a pain relief enhancer during regional anesthesia is still being researched. In this clinical trial, researchers are testing whether adding magnesium sulfate to the anesthetic ropivacaine can provide similar long-lasting pain control after mastectomy surgery compared to another medication called dexmedetomidine.
Dexmedetomidine
Dexmedetomidine is a sedative medication that is given through injection into a vein or added to local anesthetics during nerve block procedures to enhance and prolong pain relief after surgery. It works by activating specific receptors in the brain and spinal cord that reduce the sensation of pain and help patients feel calmer and more relaxed. This medication is approved and widely used in hospitals for sedation during procedures and in intensive care units, and research has shown it can effectively extend the duration of pain control when combined with local anesthetics. In this study, it serves as the comparison treatment to determine if magnesium sulfate can achieve similar pain-relieving results in patients undergoing mastectomy surgery.
Ropivacaine
Ropivacaine is a local anesthetic medication that is injected near nerves to temporarily block pain signals from reaching the brain during and after surgical procedures. It works by preventing sodium from entering nerve cells, which stops the nerves from sending pain messages to the brain and spinal cord. This medication is widely approved and used in medical practice for various types of regional anesthesia and pain management during surgeries. In this clinical trial, ropivacaine is the main pain-blocking medication being used in the nerve block, and researchers are studying whether adding magnesium sulfate or dexmedetomidine to it can make the pain relief last longer after breast cancer 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.