Project Details
Description
The NIHR-HTA funded CAMELOT trial opened for recruitment on the 9th of January 2023 (ISRCTN: 15475290). The study aims to find out whether adding Rectus Sheath Catheters (RSCs) to standard analgesia 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.
Intervention/Comparator: Patients are randomly assigned to one of two groups:
-the Intervention group receives two RSCs with an infusion of Local Anaesthesia for 72 hours from the end of surgery plus standard analgesia, including PCA
-the Comparator group receives standard analgesia, including PCA, but no RSCs. Identical-looking catheters (sham) will be attached (not sutured) on the skin surface, but no local anaesthetic will be given.
Blinding: Participants and research nurses directly involved with data collection will be blinded to group allocation by using sham RSC in the comparator group and concealment of the LA infusion devices in opaque bags. Sites will receive training on trial procedures and the surgical insertion of rectus sheath catheters after midline incision laparotomy before opening for recruitment.
The Primary outcome is Mean Overall Benefit of Analgesia (OBAS) score measured daily in the first 5 postoperative days. OBAS is a patient-reported composite endpoint of pain scores, opioid side-effects, and patient satisfaction.
We aim to recruit 750 patients over 3 years with a target randomisation rate of 2-3 patients per centre per month and are still looking for additional centres to take part in CAMELOT. Please get in touch with [email protected] if you might be interested.
https://bristoltrialscentre.blogs.bristol.ac.uk/details-of-studies/camelot/
Intervention/Comparator: Patients are randomly assigned to one of two groups:
-the Intervention group receives two RSCs with an infusion of Local Anaesthesia for 72 hours from the end of surgery plus standard analgesia, including PCA
-the Comparator group receives standard analgesia, including PCA, but no RSCs. Identical-looking catheters (sham) will be attached (not sutured) on the skin surface, but no local anaesthetic will be given.
Blinding: Participants and research nurses directly involved with data collection will be blinded to group allocation by using sham RSC in the comparator group and concealment of the LA infusion devices in opaque bags. Sites will receive training on trial procedures and the surgical insertion of rectus sheath catheters after midline incision laparotomy before opening for recruitment.
The Primary outcome is Mean Overall Benefit of Analgesia (OBAS) score measured daily in the first 5 postoperative days. OBAS is a patient-reported composite endpoint of pain scores, opioid side-effects, and patient satisfaction.
We aim to recruit 750 patients over 3 years with a target randomisation rate of 2-3 patients per centre per month and are still looking for additional centres to take part in CAMELOT. Please get in touch with [email protected] if you might be interested.
https://bristoltrialscentre.blogs.bristol.ac.uk/details-of-studies/camelot/
Key findings
Trial in progress
Recruitment started January 2022
Recruitment started January 2022
| Acronym | CAMELOT |
|---|---|
| Status | Active |
| Effective start/end date | 1/01/22 → 30/09/26 |
| Links | https://bristoltrialscentre.blogs.bristol.ac.uk/details-of-studies/camelot/ |
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