A trial to find the best way of controlling pain during and after pleurodesis (TIME1 Trial)

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 3

Pleurodesis means sealing the space between the 2 outer linings of the lungs (the pleura) so that fluid can’t collect there. This fluid build up is called a pleural effusion and it can cause shortness of breath. 

More about this trial

Doctors can treat pleural effusions by draining off the fluid through a tube, called a chest tube. They may also put talc through the chest tube to seal up the space around the lung and stop the fluid coming back again.  But this can cause pain and discomfort. The researchers in this trial wanted to find the best way of controlling this pain.

Diagram for TIME1

Doctors can use a large or small size chest tube for the pleurodesis. And they usually give people painkillers when they have this procedure. They sometimes use an opioid painkiller called Oramorph (morphine), or a non steroid anti inflammatory drug (NSAID) called ibuprofen. In this trial, some people had morphine and some people had ibuprofen for pain.

The aims of this trial were to find out

  • The best way of controlling pain during and after pleurodesis
  • Whether size of chest tube or type of painkillers affect how well pleurodesis works

Summary of results

The trial team found that there was no difference in pain scores between the 2 different types of painkillers. Having a small chest tube resulted in less pain and discomfort but the fluid build up was more likely to come back in this group.

320 people took part in this trial. 

206 people had a large chest tube put in. This is because their doctor needed to have a look at the lining of their lung with a small camera. This is called a thoracoscopy. Open a glossary item 

They were then put into 1 of 2 treatment groups at random

  • 103 had the morphine
  • 103 had the ibuprofen 

114 people didn’t need a thoroscopy and were put into 1 of 4 treatment groups at random

  • 28 had a large tube and morphine
  • 29 had a large chest tube and ibuprofen
  • 29 had a small chest tube and morphine
  • 28 had a small chest tube and ibuprofen

Everyone completed a pain questionnaire after the pleurodesis at

  • 1 week
  • 1 month 
  • 3 months
  • 6 months

People also had a chest x-ray or ultrasound scan 1 month and 3 months after the pleurodesis.

When the trial team looked at the results, they found 

  • No difference in pain scores between the 2 types of painkillers. But people who had ibuprofen needed pain relief more frequently.
  • People who had smaller chest tubes reported less pain but the fluid build up was more likely to come back at 3 months

The trial team concluded that there was no difference in pain scores. Having a smaller chest tube was a bit less painful but wasn’t as successful as the larger tube to stop the fluid building up again.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Dr Najib Rahman

Supported by

Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

2132

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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