PAROCAINE : Evaluation of the Clinical Tolerance of an Intra-Parotid Injection of Bupivacaine Combined with Dexamethasone After Parotidectomy for a Benign Tumor – Prospective Single-Center Cohort Study
This research study is for people having an operation to remove a non-cancerous lump from their parotid gland, which is a major salivary gland in your face. The study is testing a new way to help with pain and other issues after this surgery. Doctors will inject a combination of two medicines, bupivacaine (a painkiller) and dexamethasone (a medicine to reduce swelling), into the area during the operation. Researchers will then closely monitor participants for 15 days to check if there are any local side effects from the injection. They will also measure pain levels, look for problems with healing like fluid leaks or infections, and ask surgeons about how easy the injection was to give. This is a Phase II study, meaning it's an early stage of testing to see if the treatment is safe and shows promise.
At a glance
What is this study about?
This study is called 'PAROCAINE' and it's looking into a new way to help people who are having an operation called a parotidectomy. This surgery removes a non-cancerous lump from a gland in your face called the parotid gland. The main goal of the study is to see if an injection given during this surgery can help with pain and other issues afterwards.
The injection being tested contains two medicines: bupivacaine, which is a local anaesthetic (a painkiller that numbs the area), and dexamethasone, which is a type of steroid that can reduce swelling. Researchers want to find out if giving this combination of medicines during the operation helps patients recover more comfortably.
They will be carefully watching for any local side effects from the injection itself in the first 15 days after surgery. They will also be asking about your pain levels, checking for any problems with how the wound heals, and looking for other complications like salivary fistulas (a small leak of saliva). The surgeons will also provide feedback on how straightforward it was to give the injection. This is an early-stage study, so it's about exploring whether this treatment is safe and worth further investigation.
Key takeaways
- This study evaluates an injection during surgery for non-cancerous parotid lumps.
- It tests a combination of bupivacaine (pain relief) and dexamethasone (anti-swelling).
- The main focus is to check for any local side effects from the injection.
- Researchers will also track pain levels and how wounds heal over 15 days.
- It's an early-stage study to see if the treatment is safe and promising.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.
Critically, you must be scheduled to have a specific type of surgery called a partial parotidectomy. This operation is done to remove a non-cancerous lump from your parotid gland. This means the study is only for people who definitely need this particular operation for a benign (non-cancerous) parotid tumour.
If you meet these basic criteria, your doctor will be able to confirm if your specific medical situation means you can take part in this research.
- Are you 18 years old or older?
- Are you scheduled for surgery to remove a non-cancerous lump from your parotid gland?
- Do you understand that this is an exploratory research study?
- Are you comfortable with attending follow-up appointments for 15 days after surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, during your parotidectomy operation, you will receive an injection containing bupivacaine and dexamethasone. After your surgery, the research team will closely monitor you for 15 days. You will be asked about your pain levels on specific days (day 0, 1, 2, 4, 6, 9, 12, and at your 15-day follow-up appointment) using a simple scale of 0 to 10. The doctors will also check your surgical site for any issues like fluid leaks or problems with healing during your 15-day follow-up. You might also be asked to complete a short questionnaire about how your wound is healing. Your participation will last for approximately 15 days in total, from the day of your surgery to your final follow-up.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is a parotid gland?
The parotid gland is one of your main salivary glands, located just in front of and below your ear. It produces saliva that helps with digestion.
What does 'benign tumor' mean?
A 'benign tumor' means it's a non-cancerous lump or growth. It doesn't spread to other parts of your body.
What is bupivacaine and dexamethasone?
Bupivacaine is a medicine used to numb an area and relieve pain. Dexamethasone is a steroid that helps reduce swelling and inflammation.
How long will I be involved in the study?
You'll be involved for about 15 days in total, from your surgery day through to a follow-up appointment.
Will this injection replace my usual pain relief?
The study aims to see if this injection can help with pain, but your doctors will discuss all your pain relief options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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