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RecruitingNAINTERVENTIONAL

EUS-CPN With and Without Bupivacaine

This research is investigating a procedure called EUS-CPN (Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis) which is designed to help with pain caused by pancreatic cancer. During this procedure, a special ultrasound scope is used to guide an injection of alcohol near nerves in the stomach area that are linked to pain. Doctors usually give a local anaesthetic called bupivacaine right before the alcohol injection, believing it might stop pain during and after the procedure. However, it's not clear if bupivacaine actually helps, or if it might even make the alcohol treatment less effective. There's also a small risk with bupivacaine if it accidentally enters the bloodstream. This study aims to find out if leaving out bupivacaine makes the EUS-CPN procedure better or worse for long-term pain control.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
180
Start
07 Oct 2021
Estimated completion
01 Dec 2029

What is this study about?

When someone has pancreatic cancer, pain can be a big problem, greatly affecting their daily life. Standard painkillers often don't work well or come with side effects like sickness or constipation. This is where a procedure called EUS-CPN comes in. It's a way to directly target the nerves in the abdomen that are sending pain signals.

During an EUS-CPN procedure, doctors use a special flexible tube with an ultrasound camera on the end. This is gently guided into the stomach to get a clear view of a group of nerves called the celiac plexus. Once these nerves are located, a fine needle is passed through the tube to inject a small amount of alcohol around them. This alcohol helps to block the pain signals from reaching the brain, offering relief. The procedure is quite quick, usually taking about 5 minutes.

Normally, doctors first inject a local anaesthetic called bupivacaine before the alcohol. They do this because they believe it might reduce pain during and immediately after the procedure. However, there isn't much clear evidence to show if bupivacaine truly makes a difference to pain relief, whether short-term or long-term. There's also a small concern that bupivacaine might dilute the alcohol, making it less effective at blocking the pain signals. In rare cases, if bupivacaine accidentally enters the bloodstream, it could cause serious heart problems. This study aims to explore whether omitting the bupivacaine injection changes how well the pain treatment works or whether it's safer.

Key takeaways

  • This study compares two ways of performing a pain-relief procedure for pancreatic cancer.
  • It aims to see if leaving out a local anaesthetic (bupivacaine) improves pain control or safety.
  • The procedure, EUS-CPN, involves injecting alcohol near nerves causing pain.
  • The goal is to find the most effective and safest method for long-term pain relief.
  • It could offer better ways to manage pain for people with pancreatic cancer.

Who may be eligible?

This study is open to adults aged 18 and older, regardless of their gender. To be considered, you would need to have been diagnosed with pancreatic cancer and experience pain in your tummy or back that doctors believe is related to the cancer.

Your pain should have started within the last three months, be constant, and felt mainly in the centre, possibly spreading to your back. Importantly, doctors must confirm that there isn't another obvious reason for your pain. Another key point is that surgery must not be an option for managing your pancreatic cancer.

You would not be able to join the study if you are allergic to bupivacaine, which is a local anaesthetic. Also, the doctors need to be able to safely reach the specific group of nerves (celiac axis) with the ultrasound procedure.

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.

  1. Are you 18 years old or older?
  2. Do you have pancreatic cancer-related abdominal or back pain?
  3. Is surgery not an option for your pancreatic cancer?
  4. Are you NOT allergic to bupivacaine?
  5. Has your doctor confirmed that the celiac plexus nerves are accessible for this procedure?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll undergo the EUS-CPN procedure. During this, you'll be given a mild sedative to help you relax. The procedure itself usually takes about 5 minutes. After the procedure, the medical team will monitor you closely. We don't have information on specific follow-up visits or the total duration of your involvement from this summary, but these details would be fully explained by the study team.

Potential risks and benefits

Potential benefits of taking part could include better and perhaps longer-lasting pain relief from your pancreatic cancer, which could significantly improve your quality of life. The study aims to find the safest and most effective way to provide this pain relief. Every medical procedure has some risks; for instance, the alcohol injection itself can cause discomfort, and if bupivacaine is used, there's a very rare but serious risk if it enters the bloodstream. The study aims to understand these risks better. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Centre de recherche du Centre hospitalier de l'Université de Montréal
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is EUS-CPN?

EUS-CPN is a procedure that uses a special ultrasound camera to guide an injection of alcohol near nerves to help relieve pain from pancreatic cancer.

Why are doctors doing this study?

Doctors want to find out if giving a painkiller called bupivacaine during EUS-CPN actually helps, or if it's better and safer to not use it for long-term pain relief.

What is bupivacaine normally used for in this procedure?

Bupivacaine is normally given right before the alcohol injection, as doctors thought it might reduce pain during and immediately after the procedure.

Who can take part in this study?

Adults aged 18 or older with pancreatic cancer-related pain, who cannot have surgery, and are not allergic to bupivacaine may be eligible.

How long does the EUS-CPN procedure take?

The actual injection part of the EUS-CPN procedure usually takes about 5 minutes.

How to find out more

CHARLES MACKAY, RN

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "EUS-CPN With and Without Bupivacaine…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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