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Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor

RecruitingEARLY Phase 1Ages 18 Years - anyAllCentre Hospitalier Universitaire de Nīmes
NCT07812259 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

There has been a paradigm shift toward less invasive surgical techniques for parotidectomies, primarily to mitigate post-surgical complications. However, preserving more parotid tissue than with traditional methods can lead to an increased incidence of salivary fistulas and sialoceles after parotidectomy. The incidence of sialoceles varies considerably from 4.9% to 39%, while salivary fistula rates after parotidectomy range from 1% to 21%. Other wound complications, such as wound dehiscence, inflammation, and infection, can also occur, typically within the first month following surgery. No preventive technique has yet demonstrated clear efficacy or superiority in clinical practice. Bupivacaine is an amino-amide commonly used for local anesthesia. With its long-acting anesthetic effects, bupivacaine blocks the autonomic pathways (parasympathetic and sympathetic), then the sensory pathway

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📋 Eligibility rules (as published)
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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What it tests

  • Intraparotid injection of bupivacaine/ dexamethasone
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Where

1 site
Centre Hospitalier de Nimes
Nîmes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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