Overview
Sponsor-declared trial summary
Indication opératoire validée de parotidectomie partielle pour tumeur parotidienne
To evaluate the clinical tolerance (safety, adverse effects) of an injection of a mixture of bupivacaine (100 mg) and dexamethasone (2 mg) into parotid tissue up to 15 days after partial parotidectomy for a benign tumor.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nimes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Decision date (initial)
- 2026-03-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CHU NIMES
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the clinical tolerance (safety, adverse effects) of an injection of a mixture of bupivacaine (100 mg) and dexamethasone (2 mg) into parotid tissue up to 15 days after partial parotidectomy for a benign tumor.
Secondary objectives 4
- To assess postoperative pain using a standardized scale (VAS) during the 15-day follow-up period.
- To evaluate the prevalence of salivary fistulas or sialoceles.
- To assess wound-healing quality at 15 days of follow-up.
- To evaluate the feasibility of injecting bupivacaine/dexamethasone into parotid tissue after parotidectomy.
Conditions and MedDRA coding
Indication opératoire validée de parotidectomie partielle pour tumeur parotidienne
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Validated surgical indication for partial parotidectomy for parotid tumor.
- Age ≥ 18 years
- For patients of childbearing age, active contraception method.
- Person affiliated with or beneficiary of a social security system.
Exclusion criteria 5
- History of allergic reaction to aminoamide local anesthetics.
- Severe neurological history (epilepsy, peripheral neuropathies).
- History of cardiovascular risk factors (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 or kidney failure).
- Acidosis, sepsis.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Collection within 15 days of injection of any local side effects related to the injection of bupivacaine.
Secondary endpoints 4
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP10332310 · ATC
- Active substance
- Dexamethasone Acetate
- Route of administration
- INJECTION
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP131295 · ATC
- Active substance
- Bupivacaine Hydrochloride
- Route of administration
- INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nimes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nimes
- Address
- Place Du Professeur Robert Debre
- City
- Nimes
- Postcode
- 30900
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- Pr Benjamin LALLEMANT
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- Sabrina NICOLAS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOLE_2025-524358-32-00 | 1.1 |
| Protocol (for publication) | D1_PROTOCOLE_2025-524358-32-00_trackchanges | 1.1 |
| Recruitment arrangements (for publication) | K1_document additionnel_2025-524358-32-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2025-524358-32-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_2025-524358-32-00_PAROCAINE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_2025-524358-32-00_PAROCAINE_tc | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Donnees utilisation Parocaine - Bupivacaine et Dexamethasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Donnees utilisation Parocaine - Bupivacaine et Dexamethasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_BUPIVACAIN_11102021 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_dexamethasone_26062024 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocole synopsis_EN_2025-524358-32-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocole synopsis_FR_2025-524358-32-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-01 | France | Acceptable 2026-03-02
|
2026-03-19 |