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NCT06244732 · ClinicalTrials.gov record · last posted 2026-07-02

Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)

Study acronym: POPEYE
StatusRecruiting
PhaseNot applicable
Started2024-02-19
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2024-02-05; most recent amendment 2026-07-01. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-03-05
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT06244732
Lead Sponsor IRCCS Policlinico S. Donato
Conditions Postoperative Pain, Abdominal Aortic Aneurysm
Enrollment 60 participants
Start Date 2024-02-19
Primary Completion 2027-02 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-02