"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing different ways of controlling pain after keyhole surgery to remove part of the bowel
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new way of giving local anaesthetic when you have keyhole surgery to remove part of your bowel.
Surgery is one of the main treatments for bowel cancer. In recent years, surgeons have developed a type of operation called keyhole or laparoscopic surgery. The surgeon makes small cuts or holes in your abdomen. These are the ‘keyholes’. They then put surgical instruments and a camera through the keyholes to carry out the operation.
To reduce the amount of pain you have after surgery, surgeons usually inject
In this study, researchers are looking at giving local anaesthetic in a different way. Once you are asleep under
The aim of the study is to see if injecting local anaesthetic into the wall of your abdomen before surgery reduces the amount of pain you get and the amount of painkiller you need after surgery. The researchers also want to see if this method of pain control helps people to eat and drink sooner and whether they go home from hospital earlier.
Who can enter
You may be able to enter this trial if you are at least 18 years old and are going to have keyhole (laparoscopic) surgery to remove either
- The right side of your large bowel (colon), or
- The lowest part of the bowel, just above the rectum as long as you are not going to have a stoma
You cannot enter this trial if
- You have had tummy (abdominal) pain for a long time – doctors call this chronic pain
- Your doctors think it is likely they may have to switch from keyhole surgery to open surgery during the operation
- You are allergic to morphine or local anaesthetics, or you have taken a lot of them and need to have more to get the same level of pain control (drug tolerance)
- You are very overweight (your
body mass indexis more than 35), or you weigh less than 50kg (about 8 stone)
- You have had major abdominal surgery in the past
- You cannot speak and write English
This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
Half the people taking part have anaesthetic injected into their abdominal wall (TAP block), the other half have local anaesthetic injected around the keyholes at the end of their operation.
Everybody will also have a painkiller pump to use after surgery. The trial team will check how much painkiller you use. They will also ask you how much pain you have at different times on the first 3 days after surgery. You fill in a diary while you are in hospital. In this, you note down whether you feel sick and when you
- Start eating and drinking
- First pass a bowel motion
- First get out bed
- Go home from hospital
Taking part in this study will not involve any extra hospital visits.
Side effects from the amount of local anaesthetic used in this trial are very rare. The anaesthetic drug is called bupivacaine. If you have too much, or it is injected into blood vessels, it can cause dizziness, sleepiness and very rarely, fits (seizures) or abnormal heart rhythms. The risk of these side effects is very low as the researchers work out the correct dose of bupivacaine according to your body weight. And they use an ultrasound scan to make sure they don’t inject the drug into a blood vessel.
How to join a clinical trial
Dr Nicholas Crabtree
Oxford University Hospitals NHS Trust