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Clinical Trials in the EU / 2025-524358-32-00
Completed Phase II

PAROCAINE : Evaluation of the Clinical Tolerance of an Intra-Parotid Injection of Bupivacaine Combined with Dexamethasone After Parotidectomy for a Benign Tumor – Prospective Single-Center Cohort Study

2025-524358-32-00 · tracked via the Priya Life Science EU tracker
Sponsor
Centre Hospitalier Universitaire De Nimes
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Otorhinolaryngologic Diseases
Decision date
19/03/2026
Enrollment target
10
Sites
France

Condition studied

Indication opératoire validée de parotidectomie partielle pour tumeur parotidienne

Investigational medicinal product(s)

DEXAMETHASONEBUPIVACAINE

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Collection within 15 days of injection of any local side effects related to the injection of bupivacaine.

Endpoint detail

Pain level (VAS 0-10) on D0, D1, D2, D4, D6, D9, D12, and at the D15 consultation., Collection of data on the occurrence of salivary fistula or clinical sialoma at the post-operative consultation on D15 : yes/no., Administration of a questionnaire on the quality of healing (dehiscence, inflammation, infection) at the 15-day follow-up., Feasibility questionnaire, to be completed by the surgeon on the day of surgery.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524358-32-00 on CTIS ↗ ← All trials in the EU