Bupivacaine and Epinephrine Injection Study
This study is investigating a common surgery called Endoscopic Sinus Surgery (ESS), which helps clear blocked sinuses. Normally, doctors give an injection during this operation to numb the area, stop bleeding, and help them see better. However, some past research suggests similar results might be achieved without this specific injection. This study aims to find out if using this injection (which contains pain relief and a medicine to shrink blood vessels) really does make a difference to how clearly the surgeon can see compared to not having the injection. It's for adults aged 19 and over who are having this type of sinus surgery for the first time.
At a glance
What is this study about?
If you're having an operation called Endoscopic Sinus Surgery (ESS) for problems with your sinuses, this study might be of interest. ESS is a common way to clear up ongoing sinus issues. During this surgery, doctors aim to remove any blockages, clear away inflamed areas, and generally improve how your sinuses work, often making it easier for any further nose sprays or rinses to work effectively.
Usually, during this surgery, the surgeon gives an injection directly into the nose. This injection contains two types of medicine: one to numb the area (a local anaesthetic) and another to narrow blood vessels (a vasoconstrictor). The idea behind this injection is that it helps reduce bleeding during the operation and allows the surgeon to see more clearly, making the procedure safer and potentially quicker. However, some doctors have wondered if this injection truly makes a big difference, especially since other studies have shown that just a salt-water injection (which doesn't contain these medicines) can sometimes have similar effects.
This study wants to get a clearer answer. It's designed to compare what happens when patients receive the standard injection with what happens when they don't receive any injection. The main goal is to see if having the injection really does improve the surgeon's view during the operation. By understanding this better, doctors can make more informed decisions about the best way to carry out this common surgery in the future, aiming to give patients the best possible outcomes.
Key takeaways
- The study compares a special injection during sinus surgery with no injection.
- It aims to see if the injection helps surgeons see better and reduces bleeding.
- This is for people aged 19 and over having their first sinus surgery.
- You will be randomly chosen to either get the injection or not.
- The aim is to improve future sinus surgery care based on solid evidence.
Who may be eligible?
To be part of this study, you need to be at least 19 years old and be scheduled for your first-ever Endoscopic Sinus Surgery (ESS). This includes if you're also having a septoplasty, which is an operation to straighten the wall inside your nose.
There are some reasons why you wouldn't be able to join. For example, if you have certain health conditions like cystic fibrosis, serious bleeding problems, or a severe liver illness. Also, if you've had sinus surgery before, you won't be able to take part. Researchers also can't include you if you're allergic to the medicines used in the injection (bupivacaine or adrenaline).
Other reasons for not being able to join include if you've used certain inhaled drugs in the last six months, if you have growths in your nose, or if you're taking medicines for an irregular heartbeat. Lastly, if your anaesthetist thinks you're at a high risk for complications during surgery due to conditions like uncontrolled high blood pressure, heart problems, or severe diabetes, you wouldn't be suitable for this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I at least 19 years old?
- Am I having Endoscopic Sinus Surgery for the first time?
- Do I have cystic fibrosis, severe bleeding issues, or serious heart/liver problems?
- Am I allergic to bupivacaine or epinephrine (adrenaline)?
- Have I used certain inhaled drugs in the last 6 months?
- Am I considered high-risk by my anaesthetist for surgery complications?
What does participation involve?
The specific details of what taking part involves aren't fully described here, but generally, if you join, you would be assigned to one of two groups: either you'd receive the standard injection during your sinus surgery, or you'd receive no injection at all. This choice would be made by chance, like flipping a coin. The study's main focus is on what happens during your planned Endoscopic Sinus Surgery itself. After your surgery, the doctors would assess how clearly the surgeon could see during the operation. There isn't information provided about extra visits, additional tests, or long-term follow-up beyond your standard surgical care and immediate recovery.
Potential risks and benefits
Locations (1)
- St.Paul's Hospital Sinus CenterVerified postcodeVancouver, Canada· Recruiting
Common questions
What is Endoscopic Sinus Surgery (ESS)?
It's an operation to clear blocked sinuses, remove inflamed tissue, and improve how your sinuses work.
What is the injection normally for?
It usually helps to numb the area, reduce bleeding, and help the surgeon see better during the operation.
Will I definitely get the injection if I join this study?
No, you'll be put into a group by chance. One group gets the injection, and the other doesn't.
Will this study change my surgery?
The only difference to your surgery as part of the study is whether you receive the specific injection or not.
Can I leave the study at any time?
Yes, you can decide to stop being part of the study whenever you want, and your medical care will not be affected.
How to find out more
Amin Javer
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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