Can a Nerve-Blocking injection prevent salivary complications after parotid surgery?
NCT ID NCT07812259
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
After surgery to remove a benign parotid tumor, some people develop salivary fistulas or sialoceles, which are collections of saliva that can leak or cause swelling. This pilot study tests whether injecting a long-acting local anesthetic called bupivacaine, combined with a steroid called dexamethasone, directly into the remaining parotid tissue is safe and well tolerated. Ten participants will receive the injection during surgery, and researchers will monitor them for local reactions, nerve problems, allergic responses, and changes in heart rate, blood pressure, and blood sugar. The study also tracks postoperative pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A long-acting local anesthetic (bupivacaine) mixed with a steroid (dexamethasone), injected into the parotid gland during surgery
- What this could lead to
- If it proves safe, this injection could become a simple way to reduce salivary complications and pain after parotid surgery.
- What could go wrong
- This is a very small, early-stage study with only 10 people, so it can only show whether the injection is tolerated, not whether it actually prevents complications. Rare or longer-term side effects may not appear in such a small group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Validated surgical indication for partial parotidectomy for parotid tumor. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is in a period of exclusion determined by a previous study * The patient is under safeguard of justice or state guardianship * History of allergic reaction to amino-amide-type local anesthetics. * Severe neurological history (epilepsy, peripheral neuropathies). * High-risk cardiovascular history (severe hypertension, arrhythmias, complete or incomplete heart block, heart failure, coronary artery disease, treatment with type 2 antiarrhythmic drugs). * Severe liver or kidney disease (severe liver failure or severe kidney failure). * Acidosis, sepsis. * Pregnant or breastfeeding patient. * Patient unable to give informed consent. * Patient for whom it is impossible to provide informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier de Nimes
RECRUITINGNîmes, 30000, France
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Other studies related to the condition(s) this trial covers.
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- Can a steroid outperform a standard antiemetic to stop Post-Surgery sickness?
- Can a simple wash of local anesthetic cut Post-Surgery pain and opioid use?
- A steroid-sparing strategy: could olanzapine curb chemo nausea without the metabolic toll?
- Could a lower dose of spinal anesthetic protect elderly patients during surgery?