An Early Phase 1 interventional study of Intraparotid injection of bupivacaine/ dexamethasone in Parotid Neoplasm, Bupivacaine and Dexamethasone, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Early Phase 1, Interventional, and Other
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.
27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.
This study's planned enrollment of 10 is below the median of 55 across 18 interventional studies indexed under Parotid Neoplasms.
Browse Parotid Neoplasms studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Local pain post-injection
0-10 visual analog scale
Time frame: Day 15
Local intolerance post-injection
Redness, edema, warmth, inflammation: Yes/no
Time frame: Day 15
Local neurological disturbances post-injection
Paresthesia, hypoesthesia: Yes/no
Time frame: Day 15
Allergic reactions post-injection
Rash, edema, urticaria: Yes/no
Time frame: Day 15
Heart rate
beats per minutes
Time frame: Day 15
Blood pressure
mm Hg
Time frame: Day 15
Loss of consciousness
Yes/no
Time frame: Day 15
Seizures
Yes/no
Time frame: Day 15
Nausea and vomiting
Yes/no
Time frame: Day 15
Blood gluose level
mmol/L
Time frame: Day 15
Post-parotidectomy facial nerve function alteration post-injection
Facial paralysis or facial nerve damage: Yes/no
Time frame: Day 15
Injection site damage
Hematoma or infection: Yes/no
Time frame: Day 15
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 0
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 1
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 2
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 4
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 6
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 9
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 12
Postoperative pain
Measure on a 0-10 visual analog scale
Time frame: Day 15
Prevalence of salivary fistulas or sialomas
Yes/no
Time frame: Day 15
wound dehiscence
yes/no
Time frame: Day 15
inflammation of wound
Yes/no
Time frame: Day 15
infection of wound
Yes/no
Time frame: Day 15
Feasibility of bupivacaine/dexamethasone
Successful administion of bupivacaine/dexamethasone injection: Yes/no
Time frame: Day 0
Started May 2026 (actual). Primary completion is estimated for Jun 2027, 13 months after the start.
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