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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524358-32-00

Enrollment

Registered

2026-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indication opératoire validée de parotidectomie partielle pour tumeur parotidienne

Brief summary

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

Detailed description

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.

Interventions

DRUGDEXAMETHASONE

DRUGBUPIVACAINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Collection within 15 days of injection of any local side effects related to the injection of bupivacaine.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 20, 2026