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Study on the Effect of Dexamethasone and Sodium Chloride on Pain After ACL Surgery in Adults

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What is this trial about?

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

This clinical trial is focused on patients who need surgery to repair a torn anterior cruciate ligament (ACL), which is a common knee injury. The study is investigating the use of a medication called dexamethasone sodium phosphate, which is given as an injection, to see if it can help reduce pain after the surgery. Another group of patients will receive a saline solution, which is a simple saltwater solution, for comparison. The purpose of the study is to compare the effects of these two treatments on pain levels after the surgery.

Participants in the study will undergo the ACL reconstruction surgery and will be randomly assigned to receive either the dexamethasone injection or the saline solution. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps ensure that the results are not influenced by expectations about the treatment. The study will monitor pain levels at rest and during walking, as well as any episodes of nausea and vomiting. Additionally, the study will look at how quickly participants can return to their daily activities and any potential complications from the surgery.

The trial aims to provide valuable information on whether dexamethasone can effectively reduce pain and improve recovery after ACL surgery. By comparing it to the saline solution, researchers hope to determine the best approach to managing postoperative pain and enhancing recovery for patients undergoing this common knee 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes confirming the diagnosis of a complete anterior cruciate ligament rupture and ensuring the patient is scheduled for a single-bundle anterior cruciate ligament reconstruction using an autograft.

    Eligibility criteria include being between 18 and 45 years old, having no comorbidities, and the ability to take oral medication during follow-up. Females of reproductive age will undergo a pregnancy test before surgery.

  2. Step 2

    Pre-operative preparation

    Before surgery, patients are randomly assigned to one of two groups: one receiving dexamethasone and the other receiving a saline solution. This is done to compare the effects on postoperative pain.

    The dexamethasone is administered as a solution for injection, while the saline solution is administered as a solution for infusion.

  3. Step 3

    Surgery

    The surgical procedure involves the reconstruction of the anterior cruciate ligament using an autograft, with the ULTRABUTTON™ Adjustable Fixation technique.

  4. Step 4

    Post-operative care

    After surgery, pain levels are measured using a visual analog scale (VAS) both at rest and during walking. This helps assess the effectiveness of the dexamethasone compared to the saline solution.

    The number of episodes of nausea and vomiting is recorded, and functional scores such as range of movement and length of stay are evaluated.

  5. Step 5

    Follow-up

    Patients are monitored for any surgical site infections or complications, including fever, wound infections, delayed tissue healing, and gastrointestinal bleeding.

    The study aims to evaluate the earlier return to daily activities, such as walking with crutches, without significant pain.

Who can join the trial?

8 criteria

  • Participants must be willing and able to sign an informed consent form to join the study.
  • Both males and females aged between 18 and 45 years old can participate.
  • Participants should not have any other health conditions (**comorbidities**).
  • Participants must be able to take oral medication during the follow-up period, including pain relievers (**analgesics**), medications to prevent nausea (**antiemetics**), and strong painkillers (**opioids**).
  • Females of childbearing age will have a **GRAVINDEX** test, which is a urine test to check for pregnancy, before surgery to ensure they are not pregnant. Women using birth control methods can participate.
  • Males of reproductive age are eligible to participate.
  • Participants must have a confirmed diagnosis of a complete tear of the **anterior cruciate ligament (ACL)**, verified through clinical tests.
  • Participants must be undergoing a specific type of ACL surgery called single-bundle ACL reconstruction using their own tissue (**autograft**) with a technique known as the **ULTRABUTTON™ Adjustable Fixation**.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who do not need an arthroscopic anterior cruciate ligament (ACL) reconstruction cannot participate. This is a type of knee surgery.
  • Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection or care.
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Investigated drugs

Dexamethasone is a medication used in this trial to see if it can help reduce pain after surgery. It is given around the time of surgery to see if it makes a difference in how patients feel afterward.

What is already known about the treatment

Dexamethasone – This medication is typically administered as an injection or orally in tablet form. It is currently well-established in medical practice and literature as a corticosteroid used to reduce inflammation and suppress the immune response. The main therapeutic indication in this trial is to manage postoperative pain in adult patients undergoing arthroscopic anterior cruciate ligament reconstruction. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which leads to the suppression of pro-inflammatory genes and the activation of anti-inflammatory genes. It is classified pharmacologically as a corticosteroid.

Investigated diseases

Anterior Cruciate Ligament Injury – This condition involves damage to the anterior cruciate ligament (ACL), which is one of the key ligaments that help stabilize the knee joint. It often occurs during sports activities that involve sudden stops, jumps, or changes in direction. The injury can cause pain, swelling, and a feeling of instability in the knee. Over time, if not properly managed, it may lead to decreased range of motion and difficulty in performing daily activities. The progression of the injury can vary, with some individuals experiencing chronic knee issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511559-17-00Protocol codeDXAACLEstimated enrolment88 patientsSponsorOspedale San Raffaele S.r.l.

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