Intraparotid injection of bupivacaine with dexamethasone after partial parotidectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early phase1 trial investigates the safety and tolerability of a single intraparotid injection of bupivacaine combined with dexamethasone administered after partial parotidectomy for benign parotid tumors. The approach targets reducing postoperative saliva-related complications by providing prolonged local anesthesia and anti-inflammatory effects. Participants are adults with a surgical indication for partial parotidectomy who consent to participate and meet eligibility criteria. The study design is interventional; specific endpoints and procedures are described in the protocol. No comparator is stated at this phase, and results will inform feasibility and potential for larger studies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier de Nimes
  Nîmes, France Recruiting

Study contacts

• Principal investigator: Benjamin Lallemant — Centre Hospitalier Universitaire de Nīmes
• Study coordinator: Benjamin Lallemant
• Email: benjamin.lallemant@chu-nimes.fr
• Phone: 04.66.68.36.85

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.