Bupivacaine, Dexamethasone, Parotid Neoplasm
Conditions
Keywords
Drug tolerance
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.
Interventions
DRUGIntraparotid 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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local pain post-injection | Day 15 | 0-10 visual analog scale |
| Local intolerance post-injection | Day 15 | Redness, edema, warmth, inflammation: Yes/no |
| Local neurological disturbances post-injection | Day 15 | Paresthesia, hypoesthesia: Yes/no |
| Allergic reactions post-injection | Day 15 | Rash, edema, urticaria: Yes/no |
| Heart rate | Day 15 | beats per minutes |
| Blood pressure | Day 15 | mm Hg |
| Loss of consciousness | Day 15 | Yes/no |
| Seizures | Day 15 | Yes/no |
| Nausea and vomiting | Day 15 | Yes/no |
| Blood gluose level | Day 15 | mmol/L |
| Post-parotidectomy facial nerve function alteration post-injection | Day 15 | Facial paralysis or facial nerve damage: Yes/no |
| Injection site damage | Day 15 | Hematoma or infection: Yes/no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Day 0 | Measure on a 0-10 visual analog scale |
| Prevalence of salivary fistulas or sialomas | Day 15 | Yes/no |
| wound dehiscence | Day 15 | yes/no |
| inflammation of wound | Day 15 | Yes/no |
| infection of wound | Day 15 | Yes/no |
| Feasibility of bupivacaine/dexamethasone | Day 0 | Successful administion of bupivacaine/dexamethasone injection: Yes/no |
Countries
France
Contacts
CONTACTBenjamin Lallemant
PRINCIPAL_INVESTIGATORBenjamin Lallemant
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed