Study on Pain Relief After Shoulder Surgery Using Tranexamic Acid and Sodium Chloride for Patients Undergoing Arthroscopic Procedures

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What is this study about?

This clinical trial is focused on patients who need a type of shoulder surgery called arthroscopic shoulder surgery. The study is investigating the effects of a medication called tranexamic acid, which is given through an injection into a vein during the surgery. Tranexamic acid is being studied to see if it can help reduce pain after the surgery.

The purpose of the study is to evaluate whether using tranexamic acid can decrease the need for pain relief medications, like morphine, in the first 24 hours after surgery. During the study, some patients will receive tranexamic acid, while others will receive a different solution called sodium chloride, which is often used in medical settings as a standard fluid. This will help researchers compare the effects of tranexamic acid with those of sodium chloride.

Participants in the study will have their shoulder pain assessed at different times after the surgery, including 24 hours and 7 days later. They will also be asked about their satisfaction with the anesthesia experience and the functionality of their shoulder 30 days after the surgery. The study will also monitor any side effects that occur during the trial. The goal is to gather information that could improve pain management for patients undergoing shoulder surgery in the future.

1 joining the study

Upon joining the study, ensure that the informed consent form is signed. This confirms understanding of the study and agreement to participate.

Eligibility criteria include being 18 years or older, requiring shoulder arthroscopy, and being affiliated with a social security scheme.

2 pre-surgery preparation

Before the surgery, receive information about the procedure and the medications involved.

The study involves the use of tranexamic acid and sodium chloride, both administered intravenously during the surgery.

3 surgery and medication administration

During the arthroscopic shoulder surgery, tranexamic acid is injected intravenously. This is a solution for injection.

Additionally, sodium chloride is administered as a solution for infusion.

4 post-surgery monitoring

In the 24 hours following surgery, the use of morphine treatments is evaluated. This involves a simple yes or no assessment.

Shoulder pain is assessed using a Visual Analog Scale, ranging from 0 to 100, 24 hours after surgery and again 7 days later through an online assessment.

5 experience and satisfaction evaluation

Satisfaction with the general anesthesia experience is evaluated through a questionnaire.

This helps understand the overall experience and any areas for improvement.

6 shoulder functionality assessment

Thirty days after surgery, the functionality of the shoulder is evaluated using the Subjective Shoulder Value scale and the Constant Score.

These assessments help determine the recovery progress and shoulder function.

7 adverse events monitoring

Throughout the study, any adverse events are collected and monitored.

This ensures the safety and well-being of participants during the trial.

Who Can Join the Study?

Must be a male or female aged 18 years old or more.
Must be a patient requiring shoulder arthroscopy (a type of surgery on the shoulder).
Must be affiliated to a social security scheme (have social security coverage).
Must be informed about the study and have signed the informed consent form (a document that explains the study and confirms your agreement to participate).

Who Cannot Join the Study?

Patients who do not require shoulder arthroscopy cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Arfjorgtk Suaej	Bruges	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.02.2023

Trial locations

Investigated drugs:

Morphine is a medication used to relieve severe pain. In this clinical trial, it is being evaluated for its effectiveness in managing pain after shoulder surgery. Morphine works by changing the way the brain and nervous system respond to pain, providing relief to patients who have undergone surgery.

Tranexamic Acid is a medication used to reduce bleeding. In this trial, it is administered intravenously during shoulder surgery to help control bleeding and potentially improve recovery. Tranexamic Acid works by preventing the breakdown of blood clots, which can help reduce blood loss during and after surgery.

Investigated diseases:

Arthroscopy

Shoulder Pain – Shoulder pain is a condition characterized by discomfort or pain in the shoulder area, which can result from various causes such as injury, overuse, or underlying health conditions. The pain may be acute or chronic and can affect the shoulder’s range of motion and functionality. It often begins with mild discomfort and can progress to more severe pain, impacting daily activities. The condition may involve inflammation of the shoulder joint or surrounding tissues, leading to stiffness and reduced mobility. Over time, if not addressed, shoulder pain can lead to muscle weakness and decreased shoulder function.

Trial ID:

2024-518947-40-01

Protocol code:

ASCOT

NCT ID:

NCT05302986

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pain Relief After Shoulder Surgery Using Tranexamic Acid and Sodium Chloride for Patients Undergoing Arthroscopic Procedures

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