In short
Currently, there is 1 clinical trial investigating treatments to improve recovery after ligament surgery. This trial is focused on reducing pain following anterior cruciate ligament (ACL) reconstruction surgery in adults.
Clinical trial locations
Study on the Effect of Dexamethasone and Sodium Chloride on Pain After ACL Surgery in Adults
This trial is being conducted in Italy and focuses on patients who need surgery to repair a torn anterior cruciate ligament (ACL), a common knee injury. The ACL is one of the key ligaments that helps stabilize the knee joint, and injuries often occur during sports activities involving sudden stops, jumps, or changes in direction.
Main focus: The study aims to determine whether dexamethasone, a medication given as an injection, can help reduce pain after ACL reconstruction surgery. Researchers will compare its effects to a simple saltwater solution (saline) to see if dexamethasone provides better pain relief and helps patients recover more quickly.
Investigational drug: The medication being tested is dexamethasone sodium phosphate, a corticosteroid that works by reducing inflammation in the body. It is administered as an injection around the time of surgery. Dexamethasone is already well-established in medical practice for reducing inflammation and managing various conditions, but this trial specifically examines its usefulness for postoperative pain management.
Who can participate: To join this study, participants must meet several criteria:
- Be between 18 and 45 years old
- Have a confirmed diagnosis of a complete ACL tear verified through clinical tests
- Be scheduled for a specific type of ACL surgery called single-bundle ACL reconstruction using their own tissue (autograft) with the ULTRABUTTON™ Adjustable Fixation technique
- Have no other health conditions (comorbidities)
- Be able to take oral medications during follow-up, including pain relievers, anti-nausea medications, and strong painkillers if needed
- Be willing and able to sign an informed consent form
- Females of childbearing age must have a pregnancy test before surgery to ensure they are not pregnant (women using birth control methods can participate)
Who cannot participate: The trial excludes:
- Individuals under 18 years of age
- Patients who do not need arthroscopic ACL reconstruction surgery
- People who are part of vulnerable populations who may need special protection or care
What happens during the trial: Participants will be randomly assigned to receive either dexamethasone or the saline solution. This is a double-blinded study, meaning neither the participants nor the researchers will know which treatment each person is receiving. This design helps ensure that the results are not influenced by expectations about the treatment.
After surgery, the study team will monitor pain levels both at rest and during walking using a visual analog scale. They will also track episodes of nausea and vomiting, measure how quickly participants can return to daily activities like walking with crutches, and watch for any complications such as infections, fever, delayed wound healing, or gastrointestinal bleeding.
Summary
Currently, there is only one ongoing clinical trial related to ligament surgery, specifically focusing on ACL reconstruction. This trial is taking place in Italy and is investigating whether dexamethasone can effectively reduce postoperative pain and improve recovery compared to a saline placebo. The study is designed to provide valuable information for patients undergoing this common knee surgery, potentially leading to better pain management strategies in the future. The focus on a specific surgical technique and a well-established medication suggests a practical approach to improving patient outcomes following ligament reconstruction.
