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Safety of injecting bupivacaine and dexamethasone into the parotid gland for patients undergoing surgery for a benign parotid tumor

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What is this study about?

This study focuses on patients undergoing a parotidectomy, which is a surgical procedure to remove part of the parotid gland, a large salivary gland located in front of the ear. The surgery is performed to treat a benign tumor, which is a non-cancerous growth in the gland. The purpose of the study is to evaluate the safety and side effects of a specific medication mixture injected directly into the area of the gland during the operation.

The treatment involves an injection of two substances: bupivacaine, a local anesthetic used to numb the area and reduce pain, and dexamethasone, a steroid used to decrease swelling and inflammation. Following the surgery, participants will be monitored for up to 15 days to track pain levels, the healing process, and any potential complications such as a salivary fistula, which is an abnormal opening that allows saliva to leak out of the gland.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must have a confirmed plan to undergo a partial parotidectomy, which is a surgery to remove part of the parotid gland (a large gland located in front of the ear that produces saliva) due to a tumor.
  • If you are a person who could become pregnant, you must be using an active contraception method (a reliable way to prevent pregnancy).
  • You must have social security coverage or be a beneficiary of a social security system.

Who Cannot Join the Study?

  • A history of allergic reactions to aminoamide local anesthetics, which are a specific group of medicines used to temporarily numb an area of the body.
  • A history of severe neurological conditions, such as epilepsy (a disorder causing seizures) or peripheral neuropathies (damage to the nerves outside of the brain and spinal cord that can cause numbness or weakness).
  • A history of cardiovascular risk factors, which are conditions that increase the chance of heart problems, including severe hypertension (very high blood pressure), arrhythmias (irregular heartbeats), heart block (problems with the electrical signals that control the heartbeat), heart failure (when the heart cannot pump blood effectively), or coronary artery disease (narrowing of the blood vessels that supply the heart).
  • The use of type 2 antiarrhythmic drugs, which are medicines used to control irregular heart rhythms.
  • Severe liver or kidney disease, such as liver failure (when the liver can no longer function properly) or kidney failure (when the kidneys can no longer filter waste from the blood).
  • Acidosis, which is a condition where there is too much acid in the body fluids.
  • Sepsis, which is a life-threatening reaction to a serious infection.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes 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
01.02.2026

Trial locations

Investigated drugs:

Dexamethasone is a steroid medication that is used to reduce swelling and inflammation in the body.

Bupivacaine is a local anesthetic used to numb a specific area of the body to help prevent pain during and after a procedure.

Investigated diseases:

Parotid tumor – A tumor is an abnormal growth of cells within the parotid gland, which is one of the large salivary glands located in front of the ears. These growths can be benign, meaning they are non-cancerous, or malignant. As the tumor grows, it may occupy more space within the gland tissues. In some cases, the swelling can be felt as a lump under the skin near the jawline. The progression depends on whether the cells are behaving in a controlled or uncontrolled manner.

Trial ID:
2025-524358-32-00
Protocol code:
LOCAL/2025/BL01
Trial Phase:
Therapeutic exploratory (Phase II)

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