CAMELOT - Continuous rectus sheath Analgesia in eMErgency LaparOTomy: Multi-centre, randomised sham-controlled trial of rectus sheath catheter-delivered local anaesthetic infusion compared with usual care in patients undergoing emergency bowel surgery
Every year, over 30,000 patients in the UK undergo emergency bowel surgery and face severe post-operative pain. This trial tests whether a simple catheter placed under the abdominal muscles, delivering a steady local anaesthetic drip for 72 hours, can cut that pain and reduce reliance on morphine. Current standard care relies heavily on opioid-based patient-controlled analgesia, which can slow recovery and cause side effects. Small studies suggest rectus sheath catheters (RSCs) might work better, but no large trial has confirmed it. The CAMELOT trial will randomly assign 750 patients across 15 NHS hospitals to receive either a real RSC or a sham device, with both groups also receiving usual painkillers. Neither patient nor assessor will know which group is which. If RSCs prove superior, the impact is immediate and practical: a cheap, low-tech intervention that could become routine in emergency surgery, reducing opioid use, speeding bowel recovery and mobilisation, and shortening hospital stays. The team will push for changes to clinical guidance. If not, the trial will prevent wasteful adoption of an ineffective technique. Either way, the NHS gets a definitive answer.
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BACKGROUND: In the UK over 30,000 patients/year undergo emergency laparotomy surgery. Severe post-operative pain is common after this operation. Small studies suggest that rectus sheath catheters (RSCs) may provide effective pain relief, reduce morphine use and aid recovery, but they have not been investigated in a large randomised controlled trial (RCT). AIM: To compare the clinical and cost-effectiveness of RSC vs. standard analgesia for patients undergoing emergency laparotomy surgery. DESIGN: Multi-centre, pragmatic, parallel group, superiority randomised sham-controlled trial with blinding of patients and outcome assessors; an internal pilot phase to determine feasibility of recruitment and protocol adherence; patient follow-up for 6 months. SETTING: Acute surgical services in NHS hospitals. POPULATION: Adults 18 years or over, undergoing emergency laparotomy surgery via a midline incision and eligible for inclusion in the National Emergency Laparotomy Audit. EXCLUSIONS: Clinician or patient refusal, planned epidural anaesthesia, contraindications to RSC including allergy to local anaesthetic (LA), anatomical factors making RSC insertion impossible. INTERVENTION: Insertion of RSCs with constant infusion of LA for 72 hours from the end of surgery. COMPARATOR: Sham RSCs with inactive infusion device in place for 72 hours from the end of surgery. USUAL CARE: All participants will be given standard analgesia including opioid-based patient-controlled analgesia in addition to the RSC/sham RSC. OUTCOME MEASURES: Primary: mean Overall Benefit of Analgesia Score (OBAS) on postoperative days 1-5. Secondary: Postoperative complications including pulmonary, surgical site infections and intervention complications; time to return of bowel function; time to 1st mobilisation; pain intensity at rest and on movement at 24, 48 and 72 hours; postoperative opioid use; mortality at 30 and 90 days; chronic postoperative pain; health-related quality of life; length of stay in critical care and in hospital; cost effectiveness. SAMPLE SIZE: 750 participants (375 per group), which will provide 90% power to detect a 15% relative reduction in mean OBAS assuming a standard deviation (on the logarithmic scale) of 0.65, 5% statistical significance and allowing for 10% missing data. ANALYSIS: The primary analyses will be by intention to treat and results will be reported in line with the CONSORT guidelines. The economic evaluation will be conducted from an NHS perspective at 6 months PROJECT TIMETABLE: Target randomisation rate: 2 patients/centre/month across 15 centres. Study duration 56 months: 8-mths set up, 36-mths recruitment (12-mths internal pilot, 24-mths main trial), 6-mths follow-up on all participants; 6-mths analysis and report EXPERTISE: The multidisciplinary team includes patients, anaesthetists, surgeons, pain nurse, statistician, health economist, trialists/methodologists and a UKCRC-registered clinical trials unit. ANTICIPATED IMPACT AND DISSEMINATION: Our national survey has confirmed only limited uptake of RSC into routine emergency laparotomy care. If shown to be superior, we will work closely with our stakeholders to impact clinical guidance and bring RSC into routine practice. Results will be rapidly disseminated through a variety of media, publication in peer-reviewed journals and conference presentations. The CAMELOT patient advisory group will advise on dissemination to relevant patient groups.
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