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Study on the effectiveness of dexamethasone and chloroprocaine in extending the effects of spinal anesthesia for patients undergoing knee arthroscopy

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What is this study about?

This study is being conducted to evaluate the effectiveness of dexamethasone in making the effects of spinal anesthesia last longer during a knee arthroscopy, which is a surgical procedure used to look inside and treat the knee joint. The study compares the use of dexamethasone given through an intravenous infusion, which is a method of delivering fluids directly into a vein, against a placebo. During the procedure, chloroprocaine hydrochloride is used to provide the numbing effect through a spinal injection.

The purpose of the study is to determine if adding dexamethasone can prolong the period during which a patient cannot feel sensations in specific areas of the body. The duration of the numbing effect is measured by how long it takes for the sensory block, or the loss of feeling, to decrease across certain areas of the skin. Additionally, the study monitors the time it takes for muscle movement to return to normal, known as the motor block recovery, and tracks any side effects or pain levels experienced after the surgery.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must be having a knee arthroscopy, which is a surgical procedure where a doctor uses a small camera to look inside the knee joint.
  • The surgery must last 40 minutes or less.
  • The surgery must require spinal anesthesia, which is a type of numbing medicine injected near the spine to make the lower part of your body unable to feel pain.
  • You must provide written informed consent, which means you have read and signed a document agreeing to take part in the study after understanding all the details.
  • You must be part of a social security system.
  • If you are not in menopause (the stage in life when a woman stops having monthly periods), you must have a negative pregnancy test on the day of your surgery.

Who Cannot Join the Study?

  • You cannot participate if you have an allergy or sensitivity to chloroprocaine, PABA, or other ester-type local anesthetics, which are drugs used to numb an area of the body.
  • You cannot participate if you have any general reasons why you cannot receive spinal anesthesia, which is a type of numbing medicine injected into the fluid around the spinal cord.
  • You cannot participate if you have decompensated cardiac insufficiency, which means your heart is not working well enough to meet the body’s needs.
  • You cannot participate if you have hypovolemic shock or severe hypovolemia, which means you have dangerously low levels of fluids or blood in your body.
  • You cannot participate if you have coagulopathy, which is a condition where your blood does not clot normally.
  • You cannot participate if you need intravenous regional anesthesia, a method of numbing a specific limb by injecting medicine into a vein.
  • You cannot participate if you have serious cardiac conduction problems, which are issues with the electrical signals that tell your heart when to beat.
  • You cannot participate if you have severe anemia, which means you have a very low red blood cell count.
  • You cannot participate if you have an infection at the spot where the needle goes in or a sepsis, which is a serious, body-wide infection.
  • You cannot participate if you have an allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as aspirin, ketoprofen, or celecoxib.
  • You cannot participate if an NSAID allergy has caused asthma, rhinitis (stuffy or runny nose), urticaria (hives), angioedema (swelling under the skin), or anaphylaxis (a severe, life-threatening allergic reaction).
  • You cannot participate if you have an active peptic ulcer (a sore in the stomach or intestine) or gastrointestinal bleeding (bleeding in the digestive tract).
  • You cannot participate if you have severe renal impairment, which means your kidneys are not working properly.
  • You cannot participate if you have severe hepatic impairment, which means your liver is not working properly.
  • You cannot participate if you have severe heart failure.
  • You cannot participate if you are allergic to sulfonamides, which is a specific group of chemicals.
  • You cannot participate if you have ischemic heart disease, peripheral arterial disease, or cerebrovascular disease, which are various forms of blood flow problems in the heart, limbs, or brain.
  • You cannot participate if you require a peripheral nerve block, which is numbing medicine injected near a specific nerve, such as during a knee ligamentoplasty (surgery to repair knee ligaments).
  • You cannot participate if you are unable to understand the study due to mental or language barriers.
  • You cannot participate if you are under legal protection, such as having a legal guardian or curator.
  • You cannot participate if you are currently in or planning to join another medical study.
  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you are a woman of childbearing age who is not using reliable contraception (birth control).
  • You cannot participate if you have a history of diabetes.
  • You cannot participate if you have peripheral neuropathy, which is nerve damage that causes numbness or pain in the hands or feet.
  • You cannot participate if your health is classified as ASA physical status IV, which means you have severe systemic disease that is a constant threat to your life.
  • You cannot participate if you are allergic to dexamethasone, a type of steroid used to reduce inflammation.
  • You cannot participate if you have a systemic fungal infection, which is a fungus infection throughout the whole body.
  • You cannot participate if you have recently received a live virus vaccine.
  • You cannot participate if you have been taking oral corticosteroids (steroid pills) for a long time.
  • You cannot participate if you use opioids (strong pain medicines) on a regular basis.
  • You cannot participate if you suffer from chronic pain syndromes, which are long-term, ongoing pain conditions.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ceracqsw dg lb Mzcvsi Paris France

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.06.2026

Trial locations

Investigated drugs:

Dexamethasone is a steroid medication given through a vein to see if it helps make the numbness from spinal anesthesia last longer during knee surgery.

Chloroprocaine is a medication injected into the spinal area to provide numbing and loss of sensation for the duration of the procedure.

Knee arthroscopy – This is a surgical procedure used to examine and treat problems inside the knee joint. It involves making small incisions in the skin to insert a thin tube equipped with a camera. The surgeon uses specialized tools through these incisions to repair damaged cartilage, ligaments, or other structures. The procedure typically progresses from initial visualization of the joint to the targeted surgical correction of identified issues.

Trial ID:
2023-505247-39-00
Protocol code:
2023/01
Trial Phase:
Therapeutic confirmatory (Phase III)

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