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NCT Number: NCT07812259

Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Centre Hospitalier de Nimes

Nîmes, 30000, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Benjamin Lallemant

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraparotid injection of bupivacaine/ dexamethasone

Drug
  • 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.

Primary outcomes

  1. Local pain post-injection

    Time frame: Day 15

    0-10 visual analog scale

  2. Local intolerance post-injection

    Time frame: Day 15

    Redness, edema, warmth, inflammation: Yes/no

  3. Local neurological disturbances post-injection

    Time frame: Day 15

    Paresthesia, hypoesthesia: Yes/no

  4. Allergic reactions post-injection

    Time frame: Day 15

    Rash, edema, urticaria: Yes/no

  5. Heart rate

    Time frame: Day 15

    beats per minutes

  6. Blood pressure

    Time frame: Day 15

    mm Hg

  7. Loss of consciousness

    Time frame: Day 15

    Yes/no

  8. Seizures

    Time frame: Day 15

    Yes/no

  9. Nausea and vomiting

    Time frame: Day 15

    Yes/no

  10. Blood gluose level

    Time frame: Day 15

    mmol/L

  11. Post-parotidectomy facial nerve function alteration post-injection

    Time frame: Day 15

    Facial paralysis or facial nerve damage: Yes/no

  12. Injection site damage

    Time frame: Day 15

    Hematoma or infection: Yes/no

Secondary outcomes

  1. Postoperative pain

    Time frame: Day 0

    Measure on a 0-10 visual analog scale

  2. Postoperative pain

    Time frame: Day 1

    Measure on a 0-10 visual analog scale

  3. Postoperative pain

    Time frame: Day 2

    Measure on a 0-10 visual analog scale

  4. Postoperative pain

    Time frame: Day 4

    Measure on a 0-10 visual analog scale

  5. Postoperative pain

    Time frame: Day 6

    Measure on a 0-10 visual analog scale

  6. Postoperative pain

    Time frame: Day 9

    Measure on a 0-10 visual analog scale

  7. Postoperative pain

    Time frame: Day 12

    Measure on a 0-10 visual analog scale

  8. Postoperative pain

    Time frame: Day 15

    Measure on a 0-10 visual analog scale

  9. Prevalence of salivary fistulas or sialomas

    Time frame: Day 15

    Yes/no

  10. wound dehiscence

    Time frame: Day 15

    yes/no

  11. inflammation of wound

    Time frame: Day 15

    Yes/no

  12. infection of wound

    Time frame: Day 15

    Yes/no

  13. Feasibility of bupivacaine/dexamethasone

    Time frame: Day 0

    Successful administion of bupivacaine/dexamethasone injection: Yes/no

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Lallemant

CONTACT

[email protected]

04.66.68.36.85

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Acronym: PAROCAINE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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