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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 trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Spinal anesthesia administration

    A spinal puncture is performed to provide anesthesia for the knee arthroscopy surgery. during this procedure, 40 mg of chloroprocaine hydrochloride is administered through the spinal column to numb specific areas of the body.

  2. Step 2

    Medication administration

    One of two substances is administered via intravenous infusion, which is a liquid delivered directly into a vein. the test substance is 16 mg of dexamethasone phosphate, while the placebo is 103 ml of sodium chloride (a salt solution).

  3. Step 3

    Sensory and motor monitoring

    The level of numbness and the ability to move are monitored closely after the spinal puncture. sensory block, which is the loss of feeling, is checked every 5 minutes using a pin-prick test to see how much of the body remains numb. the response is graded from no sensation to normal sharp sensation.

    The motor block, which refers to the loss of muscle movement, is also assessed every 5 minutes using the modified bromage scale. this scale measures the ability to move the hip, knee, and ankle, starting from full movement to no movement at all.

  4. Step 4

    Recovery assessment

    As the effects of the anesthesia wear off, the monitoring continues. once the numbness has decreased by a certain amount, the checks for sensation and movement occur every 10 minutes until full recovery is achieved.

    A cold test using a cold stainless-steel cylinder may be used to evaluate the return of sensation.

  5. Step 5

    Postoperative monitoring and follow-up

    After surgery, pain levels are measured using a scale from 0 to 10 at several intervals: during surgery, in the recovery area, during hospital stay, and while at home up to 24 hours later.

    The use of opioids (pain-relief medications) is recorded from the time of surgery through the first 24 hours at home.

    Any side effects occurring within 24 hours of surgery are noted, such as low blood pressure, slow heart rate, nausea, vomiting, itching, or difficulty urinating.

    A follow-up occurs to check for any headaches occurring after the spinal puncture.

Who can join the trial?

7 criteria

  • 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 trial?

32 criteria

  • 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.
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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.

What is already known about the treatment

  • Sodium chloride

    This substance is a common salt solution used as a placebo in this study and is administered through an intravenous infusion into the vein. It is a well-established medical tool used widely to maintain fluid balance and replace electrolytes in the body. It does not have a specific therapeutic effect for pain but serves as a neutral control to compare against the active medications.

  • Dexamethasone phosphate

    This medication is a type of steroid given through an intravenous infusion to help extend the effects of anesthesia. It is a widely used drug in medical practice for reducing swelling and calming the immune system. At a molecular level, it works by blocking certain chemicals in the body that trigger inflammation and sensitivity to pain.

  • Chloroprocaine hydrochloride

    This is a local anesthetic medication that is applied through an intrathecal injection into the fluid surrounding the spinal cord. It is a standard drug used in medical procedures to temporarily numb a specific area of the body. It works by blocking the movement of electrical signals along the nerve cells, which prevents the sensation of pain from reaching the brain.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505247-39-00Protocol code2023/01Estimated enrolment60 patientsSponsorCentre Medico Chirurgical Ambroise Pare Hartmann

sourced from the EU Clinical Trials Register and site verification

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