Study on Dexmedetomidine and Ropivacaine for Pain Relief in Shoulder Surgery Patients

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What is this study about?

This clinical trial is focused on patients who are scheduled for shoulder surgeries. The study is investigating the use of different doses of perineural dexmedetomidine as an additional treatment to ropivacaine for a procedure called an interscalene plexus block. This block is a type of anesthesia used to numb the shoulder area during surgery. Additionally, patients will receive dexamethasone intravenously, which means it will be administered directly into a vein.

The purpose of the study is to determine how effective different doses of dexmedetomidine are in prolonging the pain relief provided by the interscalene plexus block. The study will compare the duration of pain relief, the length of time the area remains numb, and the time it takes for muscle movement to return. It will also monitor any side effects such as nausea, vomiting, low blood pressure, or slow heart rate during the first 48 hours after surgery. The study will also track the amount of pain medication needed after surgery and the time it takes for patients to recover from anesthesia.

Participants in the study will be randomly assigned to receive different doses of dexmedetomidine along with ropivacaine and dexamethasone, or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study is expected to continue until June 2025.

1 joining the trial

Upon joining the clinical trial, you will be scheduled for an initial visit. This visit is to confirm your eligibility and to provide you with detailed information about the trial process.

You will be asked to sign a consent form, which indicates your agreement to participate in the study.

2 preparation for surgery

Before your shoulder surgery, you will receive a medication called dexamethasone through an intravenous injection. The dosage is 10 mg.

This medication is intended to help reduce inflammation and improve the effectiveness of the pain relief method being studied.

3 administration of pain relief

During the procedure, you will receive a combination of medications for pain relief. This includes ropivacaine and dexmedetomidine, which are administered through a method called perineural use, meaning they are injected near the nerves in your shoulder area.

The exact dose of dexmedetomidine will vary as the trial aims to find the most effective dose. Ropivacaine is used at a concentration of 0.67%.

4 post-surgery monitoring

After your surgery, you will be monitored for the length of time you experience pain relief, known as analgesia. This is measured by the time until you need additional pain medication.

You will also be observed for any side effects, such as nausea, vomiting, low blood pressure, or slow heart rate, during the first 48 hours after surgery.

5 follow-up assessments

In the days following your surgery, you will be asked to rate your pain using a numeric scale. This helps assess the effectiveness of the pain relief method.

Your recovery progress, including the time it takes to regain full sensation and movement in your shoulder, will be evaluated.

Who Can Join the Study?

Patients who are scheduled for elective shoulder surgery. This means the surgery is planned in advance and is not an emergency.
Patients must be within the age range of 18 to 64 years old.
Both male and female patients can participate.
Patients should not be part of a vulnerable population. This typically refers to groups who may need special protection, such as children, pregnant women, or those unable to consent for themselves.

Who Cannot Join the Study?

Patients who are not scheduled for shoulder operations cannot participate.
Individuals who are not within the age range of 18 to 65 years old are excluded.
Both male and female participants are allowed, but those who do not identify as either are excluded.
Participants who are considered part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
AZ Rivierenland	Rumst	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	03.07.2023

Trial locations

Investigated drugs:

Dexmedetomidine is a medication used in this trial to help prolong the pain relief provided by a nerve block. It is given near the nerves to enhance the effect of the main pain-relieving medication. This helps in keeping the area numb for a longer period, which can be very helpful after surgery or during recovery.

Ropivacaine is the main medication used to block pain in a specific area of the body. It is a local anesthetic, which means it numbs a particular part of the body to prevent pain during and after surgery. In this trial, it is used to block pain in the shoulder area.

Dexamethasone is a medication given through a vein to help reduce inflammation and pain. In this trial, it is used alongside the other medications to enhance their effects and provide longer-lasting pain relief. It helps in reducing swelling and discomfort after surgery.

Postoperative Nausea and Vomiting – This condition occurs after surgery and is characterized by feelings of nausea and episodes of vomiting. It typically arises within the first 48 hours following an operation. The condition is influenced by factors such as the type of anesthesia used, the duration of the surgery, and individual patient characteristics. It can lead to discomfort and may delay recovery. The severity and duration can vary, with some patients experiencing mild symptoms and others having more intense episodes. Management focuses on minimizing symptoms and ensuring patient comfort.

Trial ID:

2023-506062-31-00

Protocol code:

azr2023001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Dexmedetomidine and Ropivacaine for Pain Relief in Shoulder Surgery Patients

What is this study about?

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