Use of rectus sheath catheters (RSCs) in patients undergoing emergency bowel surgery. Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Undergoing emergency laparotomy surgery via a midline incision 3. Eligible for inclusion in the National Emergency Laparotomy Audit (NELA)
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria: 1. Planned epidural anaesthesia 2. Clinician refusal 3. Lack of mental capacity to consent to trial participation 4. Contraindications to RSC including allergy to local anaesthetic (LA), anatomical factors making RSC insertion impossible 5. Existing co-enrolment in another clinical study if: 5.1. The intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis) 5.2. It is considered too burdensome for the patient; or 5.3. It is not permitted by the other study 6. Previous enrolment in the CAMELOT trial Previous participant exclusion criteria: 1. Clinician or patient refusal to participate 2. Planned epidural anaesthesia 3. Contraindications to Rectus Sheath Catheter (RSC) including allergy to local anaesthetic (LA) 4. Anatomical factors making RSC insertion impossible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain control measured using the Overall Benefit of Analgesia Score (OBAS) over the first 5 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative complications measured using the incidence of the following postoperative complications with severity of Clavien-Dindo grade II or higher collected in the CRF/patient records within 30-days of randomisation: 1.1. Postoperative pulmonary complications (PPC) 1.2. Respiratory failure 1.3. Paralytic ileus 1.4. Incisional surgical site infection 1.5. Rectus sheath catheter/infusion-related complications 2. Time to tracheal extubation (in days) measured using data collected in the CRF/patient records between randomisation and the day of tracheal extubation 3. Time to return of bowel function (in days) measured using data collected in the CRF/patient records between randomisation and the day of the return of bowel function 4. Time to first mobilisation (in days) measured using data collected in the CRF/patient records between randomisation and the day of first mobilisation 5. Pain intensity at rest and on movement measured using data collected in the CRF/patient records on postoperative days 1, 2, 3, 4, and 5 6. Postoperative opioid use measured using data collected in the CRF/patient records in the first five days from the end of surgery 7. Mortality measured using the incidence of death collected in the CRF/patient records at 30 and 90 days from the date of randomisation 8. Chronic postoperative pain measured using the Brief Pain Inventory at 3 and 6 months from the date of randomisation 9. Health-related quality of life measured using the EQ5D-5L at 3 days, and 3 and 6 months from the date of randomisation 10. Return to work and activity measured using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) at 3 and 6 months from the date of randomisation | — |
Countries
England, Scotland, United Kingdom