Abstract
ObjectivesTo test the feasibility of a randomized controlled study design comparing epidural analgesia (EDA) with continuous wound infiltration (CWI) in respect to postoperative complications and mobility to design a future multicentre randomized controlled trial.Design, setting, participantsCWI has been developed to address drawbacks of EDA. Previous studies have established the equivalent analgesic potential of CWI compared to EDA. This is a single centre, non-blinded pilot randomized controlled trial at a tertiary surgical centre. Patients undergoing elective non-colorectal surgery via a midline laparotomy were randomized to EDA or CWI. Endpoints included recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity. No primary endpoint was defined and all analyses were explorative.InterventionsCWI with local anaesthetics (experimental group) vs. thoracic EDA (control).ResultsOf 846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis. Mobility was assessed in 44 of 62 patients and revealed no differences within the first 3 postoperative days. Overall morbidity did not differ between the two groups (measured via the comprehensive complication index). Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day. Duration of preoperative induction of anaesthesia was shorter with CWI than with EDA. Of 17 serious adverse events, 3 were potentially related to EDA, while none was related to CWI.ConclusionThis trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity. Improvements in the education and training of team members are necessary to improve recruitment.Trial registrationDRKS00008023.
Highlights
Sufficient analgesia is a prerequisite for the successful perioperative management of patients undergoing surgery and reduces postoperative complications and the development of chronic pain [1,2]
Overall morbidity did not differ between the two groups
Of 17 serious adverse events, 3 were potentially related to epidural analgesia (EDA), while none was related to continuous wound infiltration (CWI). This trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity
Summary
Sufficient analgesia is a prerequisite for the successful perioperative management of patients undergoing surgery and reduces postoperative complications and the development of chronic pain [1,2]. EDA has been criticised for causing rare, but serious adverse events, its multiple contraindications, high failure rates [6], associated high personal and material costs [7] and the associated immobilization patients due to equipment and urinary catheters [4]. Despite these disadvantages, EDA compares favourably to systematic opioid use in some surgical specialties and for high risk patients [8,9,10,11]. Depending on trial design, study population, and comparators the effect of EDA on clinically relevant outcomes such as morbidity and mortality are heterogeneous [4,13,14]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
