Abdominal Aortic Aneurysm (AAA) Clinical Trials

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Post-Operative Pain Control After Aortic EndoaneurYsmEctomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
I.R.C.C.S. Policlinico San Donato
RECRUITING
San Donato Milanese
Contact Information
Primary
Mattia Ricotti
mattia.ricotti@grupposandonato.it
+390252774236
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2027-03
Participants
Target number of participants: 60
Treatments
Experimental: RSB
In patients in the RSB Group, repeated blocks of the abdominal wall will be performed using special catheters positioned bilaterally in the rectus muscle fascia using ultrasound guidance (Ropivacaine 0.375% 20 ml per side, administered every 12 hours: at T0, T12 and T24)
Active_comparator: EA
Patients of EA Group will receive analgesia via epidural catheter (Ropivacaine 0.15% with double initial bolus and subsequent continuous infusion 5 ml/h via elastomeric pump)
Sponsors
Leads: IRCCS Policlinico S. Donato

This content was sourced from clinicaltrials.gov