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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Patients who undergoing partial parotidectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local pain post-injection

0-10 visual analog scale

Time frame
Day 15
2

Local intolerance post-injection

Redness, edema, warmth, inflammation: Yes/no

Time frame
Day 15
3

Local neurological disturbances post-injection

Paresthesia, hypoesthesia: Yes/no

Time frame
Day 15
4

Allergic reactions post-injection

Rash, edema, urticaria: Yes/no

Time frame
Day 15

Secondary outcomes

1

Postoperative pain

Measure on a 0-10 visual analog scale

Time frame
Day 0
2

Postoperative pain

Measure on a 0-10 visual analog scale

Time frame
Day 1
3

Postoperative pain

Measure on a 0-10 visual analog scale

Time frame
Day 2
4

Postoperative pain

Measure on a 0-10 visual analog scale

Time frame
Day 4

Other outcomes

Sponsors and contacts

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