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CAMELOT - Continuous rectus sheath Analgesia in eMErgency LaparOTomy

Every year in the UK, around 30,000 people need urgent surgery called an emergency laparotomy. Surgeons make a vertical cut down the stomach to treat serious tummy problems. Pain after this operation can be severe. Doctors usually give strong painkillers like morphine using a button-controlled pump. While morphine works well, it can cause sickness, sleepiness, constipation, and slow down your recovery. The CAMELOT study tests whether adding two tiny tubes (called rectus sheath catheters) into the stomach muscles can help. These tubes slowly deliver local numbing medicine for three days after surgery. Participants are randomly chosen to receive either working numbing tubes or dummy tubes, alongside standard painkillers. The study will check if these numbing tubes safely reduce pain and morphine side effects, helping people get back on their feet sooner.

At a glance

Status
Recruiting
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
750
Start
25 Jan 2023
Estimated completion
28 Feb 2027

What is this study about?

An emergency laparotomy is a major, urgent operation on the tummy. Surgeons make a cut down the middle of the abdomen to reach and treat life-threatening bowel conditions. Good pain relief after this type of surgery is vital. When pain is well managed, patients can breathe deeply, move around sooner, and heal faster.

Currently, the standard way to treat this pain is with strong opioid medicines like morphine. Patients can often press a button on a pump to give themselves small doses when they feel pain. However, morphine can cause unwanted side effects. It can make you feel sick, slow down your bowels, cause drowsiness, and affect your breathing. These side effects can keep you in hospital longer.

Doctors are exploring a newer method called rectus sheath catheters. During the operation, the surgeon gently places two thin plastic tubes into the abdominal muscle wall on either side of the cut. Local anaesthetic is then slowly passed through the tubes for about 72 hours to numb the area. The CAMELOT trial aims to find out if using these tubes truly provides better pain relief, cuts down the amount of morphine needed, and offers good value for the NHS.

Key takeaways

  • Emergency laparotomy requires a large vertical cut down the tummy and needs strong pain management afterwards.
  • The CAMELOT study tests if local numbing tubes in the tummy wall improve pain relief and speed up recovery.
  • Participants are randomly chosen to receive either active numbing tubes or dummy tubes for 72 hours.
  • All patients receive standard pain relief, such as morphine pumps, regardless of which group they are in.
  • Participation is voluntary, and taking part will not change the emergency surgery you need.

Who may be eligible?

This study is open to adults aged 18 and over who need an emergency laparotomy with a cut down the middle of the abdomen in a participating NHS hospital.

You cannot take part if you are already planned to have an epidural (a numbing injection into the spine for pain relief) or if you have a known allergy to local anaesthetics. You also cannot join if your surgeon finds that the structure of your tummy muscles makes placing the tubes unsafe or impossible.

People who lack the capacity to give informed consent, those who have taken part in this trial before, or those already enrolled in another medical study that might interfere with the results will also be excluded.

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. You are aged 18 or older.
  2. You need urgent emergency bowel surgery (laparotomy).
  3. Your operation involves a cut down the middle of your tummy.
  4. You do not have an allergy to local anaesthetic drugs.
  5. You are not planned to have an epidural injection in your back for pain.
Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into one of two groups by chance, like flipping a coin. One group will receive working numbing tubes that deliver local anaesthetic into the tummy wall for 72 hours after surgery. The other group will receive dummy tubes that deliver no medicine. Neither you nor your care team will know which group you are in, which ensures the test is fair.

The tubes are put in place while you are asleep under general anaesthetic during your planned operation. Regardless of which group you are in, you will always have access to standard pain relief, including a patient-controlled pain pump. Your hospital team will care for you as normal, checking your pain levels, recovery milestones, and safety until the tubes are removed after three days. There are usually no extra hospital visits required beyond your normal post-surgery recovery.

Potential risks and benefits

Taking part may mean you experience less pain, need fewer strong painkillers, and recover more comfortably, though this cannot be guaranteed. The risks of using these numbing tubes are very low. Rare issues include the tube accidentally disconnecting from the pump, slight bleeding, or a mild infection where the tube enters the skin. If any problem occurs, doctors will simply remove the tube and adjust your standard pain medicines. Joining is completely voluntary, and you can withdraw from the study at any time without your NHS care being affected in any way.

Locations (22)

  • North Bristol NHS Trust
    City only
    Bristol, England
  • Leeds Teaching Hospitals NHS Trust
    City only
    Leeds, England
  • Medway NHS Foundation Trust
    City only
    Gillingham, England
  • Musgrove Park Hospital
    Approximate
    Taunton, England
  • Royal Alexandra Hospital
    Approximate
    Paisley, Scotland
  • Barts Health NHS Trust
    Unverified
    London, England
  • The Dudley Group NHS Foundation Trust
    Unverified
    Dudley, England
  • Blackpool Teaching Hospitals NHS Foundation Trust
    Unverified
    Blackpool, England
  • City Hospitals Sunderland NHS Foundation Trust
    Unverified
    Sunderland, England
  • Great Western Hospitals NHS Foundation Trust
    Unverified
    Swindon, England
  • University Hospitals Birmingham NHS Foundation Trust
    Unverified
    Birmingham, England
  • The Royal Wolverhampton NHS Trust
    Unverified
    Wolverhampton, England

Common questions

Will I still get painkillers if I receive the dummy tubes?

Yes. Every participant receives standard pain relief, which usually includes a pump that lets you give yourself pain medicine when you need it.

Will putting the tubes in be painful?

No. The surgeon places the tubes while you are fully asleep under general anaesthetic during your operation.

How long will the tubes stay in my tummy?

The tubes remain in place for about 72 hours (three days) after surgery and are then gently taken out on the ward.

Can I choose whether I get the real numbing medicine or the dummy?

No. A computer randomly assigns participants to each group to make sure the trial results are completely fair and unbiased.

What happens if a tube comes loose?

If a tube disconnects, nursing staff will safely remove it to prevent infection, and your doctor will ensure you have other pain relief.

How to find out more

Jonathan Evans

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

Interested in taking part?

Register your interest

Share your details and the research team for "CAMELOT - Continuous rectus sheath Analgesia in eMErgency La…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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