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Study on the Effectiveness of Dexmedetomidine, Ropivacaine, and Dexamethasone for Pain Relief in Patients Undergoing Shoulder Surgery

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What is this study about?

This clinical trial is focused on patients who are scheduled for shoulder surgeries. The study aims to find the most effective dose of dexmedetomidine when used alongside ropivacaine for a type of anesthesia called an interscalene plexus block. This block is used to numb the shoulder area during surgery. The trial will also involve the use of dexamethasone, which will be given intravenously, meaning it will be administered directly into a vein.

The purpose of the study is to determine how different doses of dexmedetomidine can extend the duration of pain relief after the anesthesia block. Participants will receive either the study medication or a placebo. The trial will monitor various outcomes, such as how long the pain relief lasts, the duration of numbness and muscle weakness, and any side effects like nausea or changes in heart rate and blood pressure. The study will also assess the amount of pain medication needed after surgery and the time it takes for patients to recover from anesthesia.

Participants will be randomly assigned to different groups, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The trial is expected to run until June 2025, with recruitment having started in September 2023. The findings from this study could help improve pain management for patients undergoing shoulder surgery.

1 joining the study

Participation begins after being scheduled for elective shoulder surgery. Eligibility is confirmed based on specific criteria.

2 preparation for the procedure

Before the procedure, a solution containing ropivacaine and dexmedetomidine is prepared for perineural use. Ropivacaine is a local anesthetic, and dexmedetomidine is used to prolong the effect of the anesthetic block.

3 administration of medications

The solution is administered as a perineural injection to perform an interscalene plexus block. This helps in managing pain during and after the shoulder surgery.

Additionally, dexamethasone is given intravenously at a dose of 10 mg to enhance the analgesic effect.

4 monitoring and recovery

The primary focus is on the length of pain relief provided by the block. The time until additional pain medication is needed is recorded.

Secondary observations include the duration of sensory and motor block, incidence of nausea and vomiting within the first 48 hours, recovery time after anesthesia, and any side effects such as low blood pressure or slow heart rate.

Pain levels are assessed using a Numeric Rating Scale over the first 48 hours, and the total opioid consumption during this period is measured.

5 completion of the trial

The trial is expected to conclude by June 30, 2025. Data collected will contribute to understanding the efficacy of different doses of dexmedetomidine in prolonging the analgesic effect of the block.

Who Can Join the Study?

  • Patients must be scheduled for a planned shoulder surgery. This means the surgery is not an emergency and is arranged in advance.
  • Participants can be of any gender, meaning both males and females are eligible.
  • Participants should be adults, which typically means they are 18 years or older.
  • Participants should not belong to a vulnerable population. This usually refers to groups that might need special protection, like children, pregnant women, or those unable to give consent.

Who Cannot Join the Study?

  • Patients who are not scheduled for shoulder operations cannot participate.
  • Individuals who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are part of a vulnerable population, such as those who may not be able to give informed consent, are not included in this study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
AZ Rivierenland Rumst Belgium

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
29.09.2023

Trial locations

Investigated drugs:

Dexmedetomidine is being studied in this trial to see how effective it is at prolonging pain relief when used with a nerve block. It is administered around the nerves to enhance the effects of the local anesthetic.

Ropivacaine is a local anesthetic used in this trial to numb a specific area of the body. It is used in a nerve block to provide pain relief during and after surgery.

Dexamethasone is given intravenously in this trial to help reduce inflammation and prolong the pain-relieving effects of the nerve block.

Postoperative Nausea and Vomiting – This condition often occurs after surgery and is characterized by feelings of nausea and the urge to vomit. It is a common side effect of anesthesia and can vary in intensity. The symptoms typically appear within the first 24 to 48 hours after surgery. Factors such as the type of surgery, anesthesia used, and individual patient characteristics can influence its occurrence. Management usually involves monitoring and supportive care to alleviate symptoms.

Hypotension – This condition is defined by abnormally low blood pressure, which can lead to dizziness, fainting, and fatigue. It can occur during or after surgery, especially when anesthesia is involved. The condition may result from various factors, including dehydration, blood loss, or medication effects. Symptoms can vary from mild to severe, depending on the underlying cause and the individual’s health. Monitoring blood pressure and ensuring adequate fluid intake are essential during surgical procedures to prevent this condition.

Bradycardia – This condition is characterized by a slower than normal heart rate, typically fewer than 60 beats per minute in adults. It can occur during anesthesia or as a response to certain medications used in surgery. While it may not always cause symptoms, it can lead to fatigue, dizziness, or fainting if the heart rate is too slow to meet the body’s needs. The condition requires careful monitoring during surgical procedures to ensure it does not lead to complications.

Trial ID:
2023-506062-31-01
Protocol code:
azr2023001
Trial Phase:
Human Pharmacology (Phase I) – Other

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