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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 trial about?

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

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Surgery and medication administration

    During the partial parotidectomy, which is a surgical procedure to remove a part of the parotid gland (a large salivary gland located in front of the ear), an injection is performed into the parotid tissue.

    The injection contains a mixture of bupivacaine (100 mg), which is a local anesthetic used to numb the area, and dexamethasone (2 mg), which is a steroid used to reduce inflammation or swelling.

  2. Step 2

    Pain monitoring and follow-up

    Pain levels are recorded using a scale from 0 to 10 on the following days: day 0 (the day of surgery), day 1, day 2, day 4, day 6, day 9, day 12, and day 15.

    Any local side effects related to the injection are monitored for up to 15 days after the procedure.

  3. Step 3

    Final follow-up consultation

    At the 15-day consultation, information is gathered regarding the presence of a salivary fistula (an abnormal opening that allows saliva to leak out) or clinical sialoma (a collection of saliva under the skin).

    A questionnaire is completed to assess the quality of healing, specifically looking for signs such as dehiscence (the separation of a wound that has been surgically closed), inflammation, or infection.

Who can join the trial?

4 criteria

  • 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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

  • Dexamethasone acetate

    This medication is an anti-inflammatory steroid administered via injection to reduce swelling and irritation. It is a widely used and well-established medicine in clinical practice for treating various inflammatory conditions. At a molecular level, it works by blocking specific proteins that trigger the body's inflammatory response, effectively calming down the immune system. It is classified pharmacologically as a glucocorticoid.

  • Bupivacaine hydrochloride and epinephrine

    This combination is administered through an injection and is commonly used to provide long-lasting numbness and pain relief during or after surgery. Bupivacaine works by blocking the movement of sodium ions along nerve fibers, which prevents the nerves from sending pain signals to the brain. Epinephrine is added to the mixture to narrow blood vessels, which helps keep the medicine in one place longer and reduces bleeding. This treatment is classified as a local anesthetic.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524358-32-00Protocol codeLOCAL/2025/BL01Estimated enrolment10 patientsSponsorCentre Hospitalier Universitaire De Nimes

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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