A trial looking at the best way to control long term pain after lung surgery (TOPIC 2)

Cancer type:

Lung cancer

Status:

Open

Phase:

Pilot

This trial is comparing 2 ways to give pain control during chest surgery.

More about this trial

In open chest surgery the surgeon makes a cut that runs around the side of the chest called a thoracotomy. It is one of the types of surgery you might have if you have lung cancer. As part of your anaesthetic Open a glossary item, you also have pain relief. But some people have pain that lasts for months or years after surgery. 
 
At the moment, there are 2 usual ways of giving pain control during surgery. These include:
  • a nerve block to one side of the chest (this is a paravertebral blockade)
  • a nerve block to both sides of the chest (an epidural blockade)
Both types of anaesthetic pain relief are commonly used. But it is not known which type is better at reducing long term pain after surgery.
 
The main aim of the trial is to find out which method works best to control pain in the long term. 
 
Please note, you might not benefit from taking part in this trial. But it might help improve long term pain relief for people having open chest surgery.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
You may be able to join this trial if all of the following apply. 
You:
  • are due to have a type of open surgery called a thoracotomy 
  • are willing to fill in questionnaires for a year after joining the trial – these will ask about your levels of pain at 3, 6 and 12 months after your surgery
  • are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. 
You:
  • can’t have the nerve blocks for any reason, for example, you are allergic to local anaesthetics Open a glossary item, you have an infection near the wound site, you have a problem with blood clotting or a problem with the top part of your spine (thoracic spine disorders)
  • have already had a thoracotomy to the same side of the chest which the surgeon plans to operate
  • had surgery to the middle of your chest (a median sternotomy) in the last 90 days  

Trial design

This trial is taking place in the UK. The researchers need 1,026 people to take part. 
 
It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. 
 
You have surgery with 1 of the following nerve blocks: 
  • a thoracic epidural block (TEB)
  • a paravertebral blockade (PVB)

Your doctor will talk to you about having the surgery and how long you stay in hospital afterwards. 
 
Quality of life
The trial team will ask you to fill out some health questionnaires:
  • before surgery
  • just after surgery
  • the day you go home 
  • then at 3 months, 6 months and 12 months after surgery
The questionnaires will ask about any pain you have and how it affects your day to day life. Each questionnaire will take you up to 30 minutes to complete. You fill them in at home and post them back and answer some questions over the phone with a research nurse.

Hospital visits

You won’t have any extra hospital visits as a result of taking part in this trial. 

Side effects

The most common side effects of the thoracic epidural block and the paravertebral blockade are:
  • difficulty passing urine 
  • itchy skin 
  • poor pain relief (you might need some extra medication to control pain)
  • low blood pressure
We have more information about surgery for lung cancer.

Location

Aberdeen
Basildon
Belfast
Birmingham
Blackpool
Clydebank
Cottingham
Coventry
Leicester
Manchester
Nottingham
Swansea
Uxbridge

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Fang Gao Smith

Supported by

University of Birmingham
NIHR Health Technology Assessment (HTA) programme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15702

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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