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.

Study Overview

• Status: Recruiting
• Conditions: Dexamethasone; Bupivacaine; Parotid Neoplasm
• Intervention / Treatment: Drug: Intraparotid injection of bupivacaine/ dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Benjamin Lallemant; Phone Number: 04.66.68.36.85; Email: benjamin.lallemant@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30000
    • Recruiting
    • Centre Hospitalier de Nimes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Benjamin Lallemant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who undergoing partial parotidectomy	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Measure on a 0-10 visual analog scale	Day 0
Postoperative pain	Measure on a 0-10 visual analog scale	Day 1
Postoperative pain	Measure on a 0-10 visual analog scale	Day 2
Postoperative pain	Measure on a 0-10 visual analog scale	Day 4
Postoperative pain	Measure on a 0-10 visual analog scale	Day 6
Postoperative pain	Measure on a 0-10 visual analog scale	Day 9
Postoperative pain	Measure on a 0-10 visual analog scale	Day 12
Postoperative pain	Measure on a 0-10 visual analog scale	Day 15
Prevalence of salivary fistulas or sialomas	Yes/no	Day 15
wound dehiscence	yes/no	Day 15
inflammation of wound	Yes/no	Day 15
infection of wound	Yes/no	Day 15
Feasibility of bupivacaine/dexamethasone	Successful administion of bupivacaine/dexamethasone injection: Yes/no	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Benjamin Lallemant, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Drug tolerance
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Salivary Gland Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Parotid Neoplasms; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: LOCAL/2025/BL01; 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk); 2025-524358-32-00 (Other Identifier: CTIS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No