NCT06244732 Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)
| NCT ID | NCT06244732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-19 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant women * Patients being treated for chronic pain * Known allergy to drugs included in analgesia protocols * Contraindications to the use of one of the two methods provided: * refusal by the patient * infection at the puncture site * coagulopathy: 1. PTT \> 40 s and/or INR \> 1.4 2. platelet count \< 50,000/µL 3. taking antiplatelet or anticoagulant drugs that have not been discontinued in good time, according to international guidelines * Emergent intervention * Lack of consent to participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06244732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06244732 currently recruiting?
Yes, NCT06244732 is actively recruiting participants. Contact the research team at mattia.ricotti@grupposandonato.it for enrollment information.
Where is the NCT06244732 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy.
Who is sponsoring the NCT06244732 clinical trial?
NCT06244732 is sponsored by IRCCS Policlinico S. Donato. The trial plans to enroll 60 participants.