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

NCT07812259 | Recruiting Early Phase 1

• 3 other identifiers: LOCAL/2025/BL012025-524358-32-002025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parotid Neoplasm; Bupivacaine; Dexamethasone

Keywords

Drug tolerance

Outcome Measures

Primary Outcomes (12)

• Local pain post-injection

  0-10 visual analog scale

  Day 15

• Local intolerance post-injection

  Redness, edema, warmth, inflammation: Yes/no

  Day 15

• Local neurological disturbances post-injection

  Paresthesia, hypoesthesia: Yes/no

  Day 15

• Allergic reactions post-injection

  Rash, edema, urticaria: Yes/no

  Day 15

• Heart rate

  beats per minutes

  Day 15

• Blood pressure

  mm Hg

  Day 15

• Loss of consciousness

  Yes/no

  Day 15

• Seizures

  Yes/no

  Day 15

• Nausea and vomiting

  Yes/no

  Day 15

• Blood gluose level

  mmol/L

  Day 15

• Post-parotidectomy facial nerve function alteration post-injection

  Facial paralysis or facial nerve damage: Yes/no

  Day 15

• Injection site damage

  Hematoma or infection: Yes/no

  Day 15

Secondary Outcomes (13)

• Postoperative pain

  Day 0

• Postoperative pain

  Day 1

• Postoperative pain

  Day 2

• Postoperative pain

  Day 4

• Postoperative pain

  Day 6

Study Arms (1)

Patients who undergoing partial parotidectomy

EXPERIMENTAL

Drug: Intraparotid injection of bupivacaine/ dexamethasone

Interventions

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.

Patients who undergoing partial parotidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier de Nimes

Nîmes, 30000, France

RECRUITING

MeSH Terms

Conditions

Parotid Neoplasms

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Benjamin Lallemant

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Lallemant

CONTACT

04.66.68.36.85; benjamin.lallemant@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

FR (1)