About this trial
Open abdominal aortic aneurysm repair (OR-AAA) is an operation associated with high morbidity, and has 30-day mortality rates of between 4 and 14%. Post-operative pain management represents a primary anesthetic focus.
A better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery.
The modern concept of multimodal analgesia involves the association of multiple drugs and/or analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods. In this context, the addition of epidural analgesia (EA) to the intravenous administration of "traditional" analgesic drugs has assumed the role of gold standard in many surgeries, including OR-AAA.
Over time, EA has proven to be a better analgesic technique than the use of intravenous opioids alone, however there is much uncertainty regarding its ability to reduce complications, morbidity and mortality of patients.
For some time, efforts to research effective, less invasive and safe anesthetic alternatives, have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery. New approaches to post-operative pain management are emerging, including rectus sheat block (RSB).
Currently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA.
In this context, the study aims to compare two different post-operative pain management protocols, with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients (age > 18 years)
patients who have given their consent to participate in the study
patients undergoing elective "open" surgical treatment of an abdominal aortic aneurysm with a midline xipho-pubic incision.
Disqualifiers
Pregnant women
Patients being treated for chronic pain
Known allergy to drugs included in analgesia protocols
refusal by the patient
Trial design
Parallel
Treatments tested in this trial
Postoperative pain control
Procedure/SurgeryPostoperative analgesia after OR-AAA
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain evaluation
Postoperative pain will be evaluated using Numerical Rating Scale (NRS) (from 0 to 10, where 0 indicates no pain and 10 is the worst pain ever had)
Secondary outcomes
Opioids consumption
Quantify and compare the consumption of opioids administered to optimize analgesia ("rescue") in case of uncontrolled pain in the two groups during the observation period
Complications associated to postoperative analgesia
Detect the onset of complications related to the analgesia technique performed in the study groups
Sponsors and contacts
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