CAMELOT

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.

  • Funder:
  • REC Number:
  • Status: Recruitment
  • Sponsor: University Hospital Southampton NHS Foundation Trust
Castle graphic with tex: Continuous rectus sheath Analgesia in eMErgency LaparOTomy

Study summary

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 and 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.

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Protocol

CAMELOT Protocol V3.0 (PDF, 699kB)

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 us

  • Chief Investigators:Dr Mark Edwards and  Dr Ronelle Mouton
  • Trial Coordinator and Assistant coordinator: Jonathan Evans and Jenny Lamb
  • Email: CAMELOT-trial@bristol.ac.uk
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