Continuous rectus sheath Analgesia in eMErgency LaparOTomy, a multi centre, randomised sham-controlled trial of rectus sheath catheter-delivered local anaesthetic infusion compared with usual care in patients undergoing emergency bowel surgery.
Status: Open to recruitment
Sponsor: University Hospital Southampton NHS Foundation Trust
Aim: CAMELOT aims to find out whether adding Rectus Sheath Catheters to standard patient controlled analgesia (PCA) provides better pain relief, fewer side effects and complications, and greater satisfaction for patients undergoing emergency laparotomy. It will also determine whether rectus sheath catheters are safe and cost-effective.
Design: Multicentre, pragmatic, Randomised Control Trial based in NHS hospitals with patient and outcome assessor blinding, an internal pilot phase and parallel cost effectiveness analysis.
Overall participant target: 750 patients over three years.
Project Timeline: Study duration 56 months: 36-months recruitment (12-months internal pilot, 24-months main trial), 6-months follow-up on all participants.
Inclusion Criteria: Patients 18 years or over, undergoing emergency laparotomy surgery eligible for inclusion in the National Emergency Laparotomy Audit AND requiring a midline incision.
Exclusion Criteria: Participant may not enter study if ANY of the following apply:
- Clinician declines
- Patient declined consent
- Lack of mental capacity to consent to trial participation
- Planned epidural anaesthesia
- Contraindications to RSC including allergy to local anaesthetic (LA), anatomical factors making RSC insertion impossible.
Intervention/Control: Patients will be randomly assigned to one of two groups:
- the Intervention group will have two RSCs with an infusion of Local Anaesthesia for 72 hours from the end of surgery plus standard analgesia, including PCA
- the Comparator group will have standard analgesia, including PC, but no RSCs. Identical looking catheters (sham) will be attached on the skin surface, but no local anaesthetic will be given.
Protocol: CAMELOT_Protocol_V3.0
Co-enrolment: CAMELOT currently allows co-enrolment to:
- FLO-ELA – Fluid Optimisation in Emergency Laparotomy Trial, ISRCTN14729158
- SINFONIA – Sugammadex for preventIoN oF pOst-operative pulmoNary complIcAtions, ISRCTN15109717
- ROSSINI-2 – Reduction Of Surgical Site Infection using several Novel Interventions, ISRCTN78305317
- REBOUND – REsilience Breakthroughs in Older people UNdergoing cancer proceDures
- MARCH – Mucoactives in Acute Respiratory failure: Carbocisteine and Hypertonic saline
Contact Information
Chief Investigator name: Dr Mark Edwards / Dr Ronelle Mouton
Trial Coordinator/Assistant coordinator: Jonathan Evans / Jenny Lamb
Email: CAMELOT-trial@bristol.ac.uk