Parotid NeoplasmEarly Phase 1PAROCAINENCT07812259
Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor
A Early Phase 1 study testing Intraparotid injection of bupivacaine/ dexamethasone in people with Parotid Neoplasm and Bupivacaine, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Neoplasm, Bupivacaine, Dexamethasone
- What is being tested?
- Intraparotid injection of bupivacaine/ dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2026to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- Acidosis, sepsis.
- Pregnant or breastfeeding patient.
- Patient unable to give informed consent.
- Patient for whom it is impossible to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Nimes
Nîmes, 30000
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Benjamin Lallemant
About this study
Official title: 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.
Read more
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.
- Conditions
- Parotid Neoplasm, Bupivacaine, Dexamethasone
- Being tested
- Intraparotid injection of bupivacaine/ dexamethasone
- Keywords
- Drug tolerance
- Medical subject headings
- Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraparotid injection of bupivacaine/ dexamethasoneDrug
- 20 ml of 0.5% bupivacaine (5 mg/mL), i.e., a dose of 100 mg;
- 0.5 ml of dexamethasone (4 mg/mL), i.e., a dose of 2 mg.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergoing partial parotidectomy | Experimental | Not described Receives: Drug: Intraparotid injection of bupivacaine/ dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local pain post-injection
0-10 visual analog scale
Measured: Day 15
Local intolerance post-injection
Redness, edema, warmth, inflammation: Yes/no
Measured: Day 15
Local neurological disturbances post-injection
Paresthesia, hypoesthesia: Yes/no
Measured: Day 15
Allergic reactions post-injection
Rash, edema, urticaria: Yes/no
Measured: Day 15
Heart rate
beats per minutes
Measured: Day 15
Blood pressure
mm Hg
Measured: Day 15
Loss of consciousness
Yes/no
Measured: Day 15
Seizures
Yes/no
Measured: Day 15
Nausea and vomiting
Yes/no
Measured: Day 15
Blood gluose level
mmol/L
Measured: Day 15
Post-parotidectomy facial nerve function alteration post-injection
Facial paralysis or facial nerve damage: Yes/no
Measured: Day 15
Injection site damage
Hematoma or infection: Yes/no
Measured: Day 15
Secondary outcomes (13)
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 0
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 1
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 2
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 4
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 6
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 9
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 12
Postoperative pain
Measure on a 0-10 visual analog scale
Measured: Day 15
Prevalence of salivary fistulas or sialomas
Yes/no
Measured: Day 15
wound dehiscence
yes/no
Measured: Day 15
inflammation of wound
Yes/no
Measured: Day 15
infection of wound
Yes/no
Measured: Day 15
Feasibility of bupivacaine/dexamethasone
Successful administion of bupivacaine/dexamethasone injection: Yes/no
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start18 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid NeoplasmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lallemant, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812259
- Sponsor's protocol ID
- LOCAL/2025/BL01
- Other IDs
- 2025-524358-32-00, 2025
- Acronym
- PAROCAINE
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07812259
- Acronym / sponsor ID
- PAROCAINE / LOCAL/2025/BL01
- Conditions
- Parotid Neoplasm, Bupivacaine, Dexamethasone
- Keywords
- Drug tolerance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergoing partial parotidectomy | Experimental | Drug: Intraparotid injection of bupivacaine/ dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraparotid injection of bupivacaine/ dexamethasone* 20 ml of 0.5% bupivacaine (5 mg/mL), i.e., a dose of 100 mg; * 0.5 ml of dexamethasone (4 mg/mL), i.e., a dose of 2 mg. | Drug | Patients who undergoing partial parotidectomy |
Primary outcome
Local pain post-injection
Time frame: Day 15
0-10 visual analog scale
Local intolerance post-injection
Time frame: Day 15
Redness, edema, warmth, inflammation: Yes/no
Local neurological disturbances post-injection
Time frame: Day 15
Paresthesia, hypoesthesia: Yes/no
Allergic reactions post-injection
Time frame: Day 15
Rash, edema, urticaria: Yes/no
Heart rate
Time frame: Day 15
beats per minutes
Blood pressure
Time frame: Day 15
mm Hg
Loss of consciousness
Time frame: Day 15
Yes/no
Seizures
Time frame: Day 15
Yes/no
Nausea and vomiting
Time frame: Day 15
Yes/no
Blood gluose level
Time frame: Day 15
mmol/L
Post-parotidectomy facial nerve function alteration post-injection
Time frame: Day 15
Facial paralysis or facial nerve damage: Yes/no
Injection site damage
Time frame: Day 15
Hematoma or infection: Yes/no
13 secondary outcomes
Postoperative pain
Time frame: Day 0
Postoperative pain
Time frame: Day 1
Postoperative pain
Time frame: Day 2
Postoperative pain
Time frame: Day 4
Postoperative pain
Time frame: Day 6
Postoperative pain
Time frame: Day 9
Postoperative pain
Time frame: Day 12
Postoperative pain
Time frame: Day 15
Prevalence of salivary fistulas or sialomas
Time frame: Day 15
wound dehiscence
Time frame: Day 15
inflammation of wound
Time frame: Day 15
infection of wound
Time frame: Day 15
Feasibility of bupivacaine/dexamethasone
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Lallemant principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intraparotid injection of bupivacaine/ dexamethasone in people with Parotid Neoplasm and Bupivacaine, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Lallemant (04.66.68.36.85, benjamin.lallemant@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local pain post-injection (time frame: Day 15). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.