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AuthorisedTherapeutic exploratory (Phase II)Interventional

Effect of perioperative intravenous infusion of lidocaine on the postoperative course and the immune response in patients undergoing surgery for colon cancer - the PILDI study

This research, called the PILDI study, is investigating if lidocaine, a common medicine for numbing and pain relief, can improve recovery for people having surgery for colon cancer. During the operation, some patients will receive lidocaine through an intravenous (IV) drip, while others will receive a salt water drip (which acts as a comparison). The main goal is to see if patients who receive lidocaine need less strong pain medication (opioids) in the first 24 hours after their surgery. Researchers will also be looking at how quickly patients' bowels start working again after the operation. This is a Phase II study, meaning it's an early stage to explore how well and safely the treatment works.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Institute Of Oncology Ljubljana
Enrolment target
100
Start
13 Oct 2025

What is this study about?

When you have surgery, especially for something serious like colon cancer, managing pain afterwards is a big part of your recovery. Doctors often use strong pain medications called opioids, but these can sometimes have side effects like sickness, constipation, or drowsiness. This study is exploring a different approach.

Researchers want to see if giving a medicine called lidocaine during surgery can make a difference. Lidocaine is often used as a local anaesthetic, like when you get a filling at the dentist, but in this study, it's given slowly through a drip into a vein during and shortly after the operation. The idea is that this might help to reduce pain and inflammation, potentially meaning you need less of the strong opioid painkillers afterwards.

The main thing the study will measure is how much strong pain medication patients need in the first day after their surgery. They will also look at how quickly patients' digestive systems start working again, which is a good sign of recovery after bowel surgery. This research could help doctors find better ways to manage pain and speed up recovery for people having colon cancer surgery in the future.

Key takeaways

  • This study explores using lidocaine during colon cancer surgery.
  • The main aim is to see if it reduces the need for strong painkillers after the operation.
  • It also looks at how quickly patients recover, like when their bowels start working.
  • This is a Phase II study, an early stage of testing.
  • Participation involves receiving either lidocaine or salt water through a drip during surgery.
  • Your normal medical care and pain management will continue.

Who may be eligible?

This study is open to adults aged 18 and over, of any gender, who are going to have surgery for colon cancer. Because everyone is different, and cancer treatment is complex, the medical team will carefully check to make sure the study is right for you, and that you meet all the necessary health criteria.

Your doctors will need to review your overall health condition, the specific details of your colon cancer, and any other medications you are taking to determine if you can safely participate. This ensures that the study is as safe as possible for everyone involved and that the results will be meaningful.

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. Are you scheduled for surgery for colon cancer?
  3. Do you understand that you might receive either lidocaine or a salt water drip?
  4. Are you willing to have your pain medication use and recovery monitored?
  5. Are you happy for the study team to collect information from your medical records?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive care as planned for your colon cancer surgery. During your operation, you would be put into one of two groups: one group would receive lidocaine through a drip, and the other group would receive a salt water drip. You and your doctors would not know which one you are receiving – this is standard practice in studies to make sure the results are unbiased.

After your surgery, the medical team would carefully monitor how much pain medication you need and how quickly you recover. This includes keeping track of when your bowels start working again. You would have standard follow-up appointments and assessments as part of your normal cancer care, and the study team would collect information from these. The total duration of your participation would mainly focus on the perioperative period (around your surgery) and the immediate recovery.

Potential risks and benefits

Participating in research is a personal choice. A potential benefit of this study could be that if you receive lidocaine, you might experience less pain and need fewer strong painkillers after surgery, which could lead to a smoother recovery. However, there's no guarantee this will happen, and you might experience side effects from either the lidocaine or the standard treatments. The medical team will closely monitor you for any potential side effects. Remember, you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Slovenia

Common questions

What is lidocaine?

Lidocaine is a common medication used to numb areas or relieve pain. In this study, it's given through a drip.

What are opioids?

Opioids are strong pain medications, often used after surgery, but they can have side effects like nausea or constipation.

What does 'Phase II study' mean?

It means this is an early study to see if the treatment works well and is safe before it's tested on a larger group of people.

Will I know if I'm getting lidocaine or salt water?

No, neither you nor your doctors will know which treatment you are receiving until the end of the study. This is to make sure the results are fair.

Can I still get pain relief if I'm in the study?

Yes, your medical team will ensure you receive appropriate pain relief throughout your recovery, regardless of which group you are in.

How to find out more

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

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