- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07812259
Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor (PAROCAINE)
Evaluation of the Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor - A Single-center Prospective Cohort Study.
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 pathways, and finally the motor pathways. By providing prolonged blockade of the parasympathetic nerve pathways that induce salivary secretion, bupivacaine injected into the parotid tissue during surgery could be a potentially effective prophylactic agent for preventing salivary fistulas after parotidectomy. Certain adjuvants can be used locally in combination with bupivacaine to prolong the duration of nerve blocks and improve postoperative pain management. Dexamethasone is the most effective adjuvant to long-acting local anesthetics. This combination is widely used in routine practice.
Due to its sustained blockade of parasympathetic nerve fibers, intraparotid bupivacaine, combined with local dexamethasone, could be an effective tool for reducing various postoperative complications, including sialoceles and salivary fistulas, after partial parotidectomy. It could also play a major role in postoperative analgesia. Although bupivacaine is commonly used in surgical practice, there are no data regarding the injection of bupivacaine combined with dexamethasone into the parotid tissue to prevent salivary complications after partial parotidectomy. Therefore, the safety of its use when injected specifically into the parotid tissue has never been evaluated.
The aim of this pilot study is to assess the tolerability of intraparotid injection of bupivacaine combined with a local injection of dexamethasone after partial parotidectomy for a benign tumor.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Benjamin Lallemant
- Telefonnummer: 04.66.68.36.85
- E-mail: benjamin.lallemant@chu-nimes.fr
Studiesteder
-
-
-
Nîmes, Frankrig, 30000
- Rekruttering
- Centre Hospitalier de Nimes
-
Kontakt:
- Anissa Megzari
- Telefonnummer: 04.66.68.42.36
- E-mail: drc@chu-nimes.fr
-
Ledende efterforsker:
- Benjamin Lallemant
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Patients who undergoing partial parotidectomy
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Local pain post-injection
Tidsramme: Day 15
|
0-10 visual analog scale
|
Day 15
|
|
Local intolerance post-injection
Tidsramme: Day 15
|
Redness, edema, warmth, inflammation: Yes/no
|
Day 15
|
|
Local neurological disturbances post-injection
Tidsramme: Day 15
|
Paresthesia, hypoesthesia: Yes/no
|
Day 15
|
|
Allergic reactions post-injection
Tidsramme: Day 15
|
Rash, edema, urticaria: Yes/no
|
Day 15
|
|
Heart rate
Tidsramme: Day 15
|
beats per minutes
|
Day 15
|
|
Blood pressure
Tidsramme: Day 15
|
mm Hg
|
Day 15
|
|
Loss of consciousness
Tidsramme: Day 15
|
Yes/no
|
Day 15
|
|
Seizures
Tidsramme: Day 15
|
Yes/no
|
Day 15
|
|
Nausea and vomiting
Tidsramme: Day 15
|
Yes/no
|
Day 15
|
|
Blood gluose level
Tidsramme: Day 15
|
mmol/L
|
Day 15
|
|
Post-parotidectomy facial nerve function alteration post-injection
Tidsramme: Day 15
|
Facial paralysis or facial nerve damage: Yes/no
|
Day 15
|
|
Injection site damage
Tidsramme: Day 15
|
Hematoma or infection: Yes/no
|
Day 15
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative pain
Tidsramme: Day 0
|
Measure on a 0-10 visual analog scale
|
Day 0
|
|
Postoperative pain
Tidsramme: Day 1
|
Measure on a 0-10 visual analog scale
|
Day 1
|
|
Postoperative pain
Tidsramme: Day 2
|
Measure on a 0-10 visual analog scale
|
Day 2
|
|
Postoperative pain
Tidsramme: Day 4
|
Measure on a 0-10 visual analog scale
|
Day 4
|
|
Postoperative pain
Tidsramme: Day 6
|
Measure on a 0-10 visual analog scale
|
Day 6
|
|
Postoperative pain
Tidsramme: Day 9
|
Measure on a 0-10 visual analog scale
|
Day 9
|
|
Postoperative pain
Tidsramme: Day 12
|
Measure on a 0-10 visual analog scale
|
Day 12
|
|
Postoperative pain
Tidsramme: Day 15
|
Measure on a 0-10 visual analog scale
|
Day 15
|
|
Prevalence of salivary fistulas or sialomas
Tidsramme: Day 15
|
Yes/no
|
Day 15
|
|
wound dehiscence
Tidsramme: Day 15
|
yes/no
|
Day 15
|
|
inflammation of wound
Tidsramme: Day 15
|
Yes/no
|
Day 15
|
|
infection of wound
Tidsramme: Day 15
|
Yes/no
|
Day 15
|
|
Feasibility of bupivacaine/dexamethasone
Tidsramme: Day 0
|
Successful administion of bupivacaine/dexamethasone injection: Yes/no
|
Day 0
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Benjamin Lallemant, Centre Hospitalier Universitaire de Nîmes
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Mundsygdomme
- Stomatognatiske sygdomme
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer i hoved og hals
- Spytkirtelsygdomme
- Mundens neoplasmer
- Parotissygdomme
- Spytkirtelneoplasmer
- Parotid neoplasmer
- Polycykliske forbindelser
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Dexamethason
Andre undersøgelses-id-numre
- LOCAL/2025/BL01
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524358-32-00 (Anden identifikator: CTIS)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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