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AuthorisedTherapeutic use (Phase IV)Interventional

Transversus Abdominis Plane (TAP) Block vs. Laparoscopic Port Site Wound Infiltration in Patients with Colorectal Cancer Undergoing Scheduled Laparoscopic Surgery Included in the Enhanced Recovery After Surgery (ERAS) Program

This research is looking at different ways to help people with bowel cancer manage pain after keyhole surgery. Patients having this type of surgery already follow a special recovery plan. The study compares two pain relief methods: one involves injecting a pain-numbing medicine near specific nerves in the tummy (called a TAP block), and the other involves injecting the same medicine directly into the small cuts made during surgery. Doctors want to see which method leads to less pain and reduces the need for strong painkillers like morphine in the first 48 hours after the operation. They will also check if people feel sick or vomit less often with one method compared to the other.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
Enrolment target
174
Start
03 Sep 2024

What is this study about?

This study is designed for people in the UK who are having keyhole surgery for bowel cancer. Keyhole surgery, also known as laparoscopic surgery, uses small cuts and special instruments to perform the operation, which often leads to a quicker recovery than traditional open surgery.

After surgery, managing pain is very important for a good recovery. This study is comparing two ways to help with pain relief. One method is called a 'TAP block', where pain-numbing medicine is injected near a particular network of nerves in the tummy area. The other method involves injecting the same pain-numbing medicine directly into the small cuts (port sites) made during the keyhole surgery. Both of these methods are given on top of the usual care you would receive.

The main goal of the study is to find out which of these pain relief methods works best to reduce pain after surgery. Doctors will also track how much other pain medication, like strong painkillers, people need to take, and if there are differences in how often people feel sick or vomit after their operation. The hope is to improve how pain is managed for patients recovering from bowel cancer surgery.

Key takeaways

  • Compares two pain relief methods for bowel cancer keyhole surgery.
  • Aims to find out which method reduces pain and the need for strong painkillers.
  • Looks at two types of pain relief injections: near tummy nerves or around surgery cuts.
  • Involves rating your pain and tracking other painkiller use for 48 hours post-surgery.
  • Anyone 18+ having keyhole colorectal cancer surgery is potentially eligible.
  • Participation involves no extra visits, only assessments during your hospital stay.

Who may be eligible?

This study is open to both men and women who are aged 18 or older. There is no upper age limit for who can take part.

To be eligible, you must be diagnosed with bowel cancer and be scheduled to have keyhole surgery as part of your treatment. You will also need to be part of a special recovery programme designed to help people get better faster after surgery. Your doctors will be able to confirm if you meet all the necessary requirements.

It's important to discuss with your healthcare team whether this study is a good fit for you, based on your specific medical history and current health.

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. Have you been diagnosed with bowel (colorectal) cancer?
  3. Are you scheduled to have keyhole surgery for your bowel cancer?
  4. Are you following a special recovery programme (ERAS) as part of your surgical care?
  5. Are you comfortable with your pain levels being monitored for 48 hours after surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will already be having bowel cancer surgery and following a special recovery plan. You would receive one of two pain relief treatments: either an injection of pain medicine near nerves in your tummy (TAP block) or an injection of pain medicine around the small cuts made during your surgery. You won't know which one you receive until after your treatment, as it's chosen at random.

Your main involvement will be rating your pain using a simple scale (like a ruler) at specific times after your surgery: about 2 hours, 6 hours, 24 hours, and 48 hours. The medical team will also keep track of any other pain relief medicines you take, such as strong painkillers, during your hospital stay within these first 48 hours. They will also note if you experience any sickness or vomiting. There are no extra visits required beyond your normal hospital stay for surgery; all assessments happen while you are recovering in the hospital.

Potential risks and benefits

Taking part in this study could potentially help improve pain control after your surgery, possibly leading to a more comfortable recovery and less need for strong painkillers. However, as with any medical procedure, there are potential risks associated with the pain relief injections, such as bruising, infection, or a temporary feeling of numbness at the injection site, though these are generally uncommon for these types of procedures. Your safety and well-being are a top priority, and you'll be closely monitored by your medical team throughout. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Common questions

What is keyhole surgery?

Keyhole (laparoscopic) surgery uses small cuts and a camera to operate, often leading to faster recovery than open surgery.

What is a TAP block?

A TAP block is an injection of pain-numbing medicine near certain nerves in your tummy to help with pain after surgery.

Will I know which treatment I'm getting?

No, you won't know which pain relief method you receive until after your treatment, as it's chosen randomly by the study.

How will my pain be measured?

You'll be asked to rate your pain using a simple scale, usually from 0 (no pain) to 10 (worst possible pain), at specific times after surgery.

Will taking part change my normal care?

No, this study adds to your normal care. Your regular bowel cancer treatment and recovery plan will not be affected.

How to find out more

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

Discussion

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