Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06244732

Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)

Led by IRCCS Policlinico S. Donato · Updated on 2025-05-06

60

Participants Needed

1

Research Sites

158 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Patients being treated for chronic pain
  • Known allergy to drugs included in analgesia protocols
  • Contraindications to the use of epidural analgesia or rectus sheath block, including patient refusal, infection at puncture site, or coagulopathy (PTT > 40 s and/or INR > 1.4, platelet count < 50,000/µL, or taking antiplatelet or anticoagulant drugs not discontinued according to guidelines)
  • Emergent intervention
  • Lack of consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, Italy, 20097

Actively Recruiting

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Research Team

M

Mattia Ricotti

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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