Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 1:22 AM
Study NCT ID:
NCT06244732
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2024-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2024-01-27', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain evaluation', 'timeFrame': 'day 0 (12 h after extubation)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Opioids consumption', 'timeFrame': 'within 36 hours from extubation', 'description': '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'}, {'measure': 'Complications associated to postoperative analgesia', 'timeFrame': 'within 36 hours from extubation', 'description': 'Detect the onset of complications related to the analgesia technique performed in the study groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '26331571', 'type': 'RESULT', 'citation': 'Chang DC, Parina RP, Wilson SE. Survival After Endovascular vs Open Aortic Aneurysm Repairs. JAMA Surg. 2015 Dec;150(12):1160-6. doi: 10.1001/jamasurg.2015.2644.'}, {'pmid': '25970850', 'type': 'RESULT', 'citation': 'Hicks CW, Wick EC, Canner JK, Black JH 3rd, Arhuidese I, Qazi U, Obeid T, Freischlag JA, Malas MB. Hospital-Level Factors Associated With Mortality After Endovascular and Open Abdominal Aortic Aneurysm Repair. JAMA Surg. 2015 Jul;150(7):632-6. doi: 10.1001/jamasurg.2014.3871.'}, {'pmid': '28343694', 'type': 'RESULT', 'citation': 'Deery SE, Schermerhorn ML. Open versus endovascular abdominal aortic aneurysm repair in Medicare beneficiaries. Surgery. 2017 Oct;162(4):721-731. doi: 10.1016/j.surg.2017.01.022. Epub 2017 Mar 23.'}, {'pmid': '30528142', 'type': 'RESULT', 'citation': "Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available."}, {'pmid': '14612482', 'type': 'RESULT', 'citation': 'Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.'}, {'pmid': '23906858', 'type': 'RESULT', 'citation': 'Stenger M, Fabrin A, Schmidt H, Greisen J, Erik Mortensen P, Jakobsen CJ. High thoracic epidural analgesia as an adjunct to general anesthesia is associated with better outcome in low-to-moderate risk cardiac surgery patients. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1301-9. doi: 10.1053/j.jvca.2012.12.001. Epub 2013 Jul 29.'}, {'pmid': '11573049', 'type': 'RESULT', 'citation': 'Park WY, Thompson JS, Lee KK. Effect of epidural anesthesia and analgesia on perioperative outcome: a randomized, controlled Veterans Affairs cooperative study. Ann Surg. 2001 Oct;234(4):560-9; discussion 569-71. doi: 10.1097/00000658-200110000-00015.'}, {'pmid': '18692893', 'type': 'RESULT', 'citation': 'Wijeysundera DN, Beattie WS, Austin PC, Hux JE, Laupacis A. Epidural anaesthesia and survival after intermediate-to-high risk non-cardiac surgery: a population-based cohort study. Lancet. 2008 Aug 16;372(9638):562-9. doi: 10.1016/S0140-6736(08)61121-6. Epub 2008 Aug 8.'}, {'pmid': '11965272', 'type': 'RESULT', 'citation': 'Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.'}, {'pmid': '20124282', 'type': 'RESULT', 'citation': "Ali M, Winter DC, Hanly AM, O'Hagan C, Keaveny J, Broe P. Prospective, randomized, controlled trial of thoracic epidural or patient-controlled opiate analgesia on perioperative quality of life. Br J Anaesth. 2010 Mar;104(3):292-7. doi: 10.1093/bja/aeq006. Epub 2010 Feb 1."}, {'pmid': '22786494', 'type': 'RESULT', 'citation': 'Nishimori M, Low JH, Zheng H, Ballantyne JC. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD005059. doi: 10.1002/14651858.CD005059.pub3.'}, {'pmid': '11684971', 'type': 'RESULT', 'citation': 'Norris EJ, Beattie C, Perler BA, Martinez EA, Meinert CL, Anderson GF, Grass JA, Sakima NT, Gorman R, Achuff SC, Martin BK, Minken SL, Williams GM, Traystman RJ. Double-masked randomized trial comparing alternate combinations of intraoperative anesthesia and postoperative analgesia in abdominal aortic surgery. Anesthesiology. 2001 Nov;95(5):1054-67. doi: 10.1097/00000542-200111000-00006.'}, {'pmid': '27603002', 'type': 'RESULT', 'citation': 'Bardia A, Sood A, Mahmood F, Orhurhu V, Mueller A, Montealegre-Gallegos M, Shnider MR, Ultee KH, Schermerhorn ML, Matyal R. Combined Epidural-General Anesthesia vs General Anesthesia Alone for Elective Abdominal Aortic Aneurysm Repair. JAMA Surg. 2016 Dec 1;151(12):1116-1123. doi: 10.1001/jamasurg.2016.2733.'}, {'pmid': '26731032', 'type': 'RESULT', 'citation': 'Guay J, Kopp S. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD005059. doi: 10.1002/14651858.CD005059.pub4.'}, {'pmid': '31672606', 'type': 'RESULT', 'citation': 'Greco KJ, Brovman EY, Nguyen LL, Urman RD. The Impact of Epidural Analgesia on Perioperative Morbidity or Mortality after Open Abdominal Aortic Aneurysm Repair. Ann Vasc Surg. 2020 Jul;66:44-53. doi: 10.1016/j.avsg.2019.10.054. Epub 2019 Oct 28.'}, {'pmid': '30385186', 'type': 'RESULT', 'citation': 'Monaco F, Pieri M, Barucco G, Karpatri V, Redaelli MB, De Luca M, Mattioli C, Bove T, Melissano G, Chiesa R, Landoni G, Zangrillo A. Epidural Analgesia in Open Thoraco-abdominal Aortic Aneurysm Repair. Eur J Vasc Endovasc Surg. 2019 Mar;57(3):360-367. doi: 10.1016/j.ejvs.2018.09.027. Epub 2018 Oct 29.'}, {'pmid': '30161292', 'type': 'RESULT', 'citation': 'Salicath JH, Yeoh EC, Bennett MH. Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. Cochrane Database Syst Rev. 2018 Aug 30;8(8):CD010434. doi: 10.1002/14651858.CD010434.pub2.'}, {'pmid': '16169893', 'type': 'RESULT', 'citation': 'Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.'}, {'pmid': '22286517', 'type': 'RESULT', 'citation': 'Hakim SM, Narouze S, Shaker NN, Mahran MA. Risk factors for new-onset persistent low-back pain following nonobstetric surgery performed with epidural anesthesia. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):175-82. doi: 10.1097/AAP.0b013e3182411048.'}, {'pmid': '8895281', 'type': 'RESULT', 'citation': 'Curatolo M, Scaramozzino P, Venuti FS, Orlando A, Zbinden AM. Factors associated with hypotension and bradycardia after epidural blockade. Anesth Analg. 1996 Nov;83(5):1033-40. doi: 10.1097/00000539-199611000-00023.'}, {'pmid': '10588551', 'type': 'RESULT', 'citation': 'Ready LB. Acute pain: lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):499-505. doi: 10.1016/s1098-7339(99)90038-x. No abstract available.'}, {'pmid': '27035462', 'type': 'RESULT', 'citation': 'Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394.'}, {'pmid': '35139802', 'type': 'RESULT', 'citation': 'Dobson SW, Weller RS, Edwards C, Turner JD, Jaffe JD, Reynolds JW, Henshaw DS. A randomized comparison of loss of resistance versus loss of resistance plus electrical stimulation: effect on success of thoracic epidural placement. BMC Anesthesiol. 2022 Feb 9;22(1):43. doi: 10.1186/s12871-022-01584-x.'}, {'pmid': '16418025', 'type': 'RESULT', 'citation': 'Kehlet H. Labat lecture 2005: surgical stress and postoperative outcome-from here to where? Reg Anesth Pain Med. 2006 Jan-Feb;31(1):47-52. doi: 10.1016/j.rapm.2005.10.005. No abstract available.'}, {'pmid': '34268624', 'type': 'RESULT', 'citation': 'Kuniyoshi H, Yamamoto Y, Kimura S, Hiroe T, Terui T, Kase Y. Comparison of the analgesic effects continuous epidural anesthesia and continuous rectus sheath block in patients undergoing gynecological cancer surgery: a non-inferiority randomized control trial. J Anesth. 2021 Oct;35(5):663-670. doi: 10.1007/s00540-021-02973-1. Epub 2021 Jul 15.'}, {'pmid': '21856077', 'type': 'RESULT', 'citation': 'Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.'}, {'pmid': '34980845', 'type': 'RESULT', 'citation': 'Kietaibl S, Ferrandis R, Godier A, Llau J, Lobo C, Macfarlane AJ, Schlimp CJ, Vandermeulen E, Volk T, von Heymann C, Wolmarans M, Afshari A. Regional anaesthesia in patients on antithrombotic drugs: Joint ESAIC/ESRA guidelines. Eur J Anaesthesiol. 2022 Feb 1;39(2):100-132. doi: 10.1097/EJA.0000000000001600.'}, {'pmid': '27575452', 'type': 'RESULT', 'citation': 'Ball L, Pellerano G, Corsi L, Giudici N, Pellegrino A, Cannata D, Santori G, Palombo D, Pelosi P, Gratarola A. Continuous epidural versus wound infusion plus single morphine bolus as postoperative analgesia in open abdominal aortic aneurysm repair: a randomized non-inferiority trial. Minerva Anestesiol. 2016 Dec;82(12):1296-1305. Epub 2016 Aug 30.'}, {'pmid': '15195324', 'type': 'RESULT', 'citation': 'Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery.\n\nThe 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.\n\nOver 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.\n\nFor 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).\n\nCurrently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA.\n\nIn 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.', 'detailedDescription': 'This is a prospective, randomized controlled, single-centre, non-profit, spontaneous study, which involves the evaluation of the control of post-operative pain in a population of adult patients admitted to the General Intensive Care Unit after elective open endoaneurysmectomy of the abdominal aorta.\n\nThe study will be conducted by analyzing two groups of patients, randomized to receive ether postoperative analgesia via epidural catheter (EA Group) or repeated blocks of the rectus fascia (RSB Group).\n\nPre- and intra-operative management In EA Group the epidural catheter will be positioned, according to the normal practices of the Operating Unit, before the operation. The insertion of the catheter will be carried out at the T10-T12 level for a maximum of 5-7 cm in the epidural space.\n\nFor both groups under study, the operation will be conducted under balanced general anesthesia, using a volatile anesthetic (Desflurane or Sevoflurane) associated with Remifentanil, with titratable doses in order to guarantee an adequate depth of anesthesia, understood as bispectral index (BIS ) between 40 and 60. Myoresolution will be maintained with the use of neuromuscular monitoring (TOF, Train Of Four).\n\nAfter intubation, the bladder catheter, nasogastric tube, central venous catheter (with ultrasound-guided technique) will be positioned and the following will be prepared:\n\n* Cell saver for blood recovery\n* Body temperature monitoring via throat probe\n* Minimally invasive arterial hemodynamic monitoring with FloTrac system and continuous detection of the following parameters:\n\n * Mean arterial pressure (MAP)\n * Cardiac Index (CI)\n * Stroke Volume Variation (SVV) These parameters, as usual, will guide the anesthetic conduct for the optimization of blood volume and intraoperative hemodynamic performance.\n* Prophylaxis of nausea and vomiting will be carried out by administering Dexamethasone 4 mg to all patients at induction and Ondansetron 4 mg before extubation\n* Upon closure of the abdominal muscle fascia, intravenous analgesia will be administered with Paracetamol 1 g, Ibuprofen 600 mg and MgSO4 2 g At the end of the surgical procedure, each patient, as usual and regardless of the study protocol, will be transferred to the General Intensive Care Unit, where monitoring and the subsequent recovery phase will continue.\n\nPost-operative management All patients will be transferred to the General Intensive Care Unit with continued sedation and mechanical ventilation, in order to standardize the close monitoring of vital functions, the recovery phase and the management of the analgesia protocol.\n\nEach patient will be eligible for awakening and extubation - and therefore for the start of the analgesia protocol - once all the following criteria have been met:\n\n* Body temperature ≥ 35.5° C\n* MAP ≥ 65 mmHg (with max basic norepinephrine dosage 0.1 mcg/kg/min)\n* TOF-Ratio ≥ 0.9 If the conditions for awakening are not respected, the clinical conditions will be optimized in order to restore the stability necessary for extubation. Patients who have not reached the aforementioned criteria within 12 hours of admission to the ICU will exit the study protocol (see "drop-out criteria").\n\nFrom the moment of awakening (T0), observation and data collection will continue in the Intensive Care Unit for a total of 36 hours.\n\nAnalgesia protocol\n\nThe administration of analgesia according to the usual protocols will begin before awakening in those patients who have met the criteria for extubation:\n\n* Group EA will receive analgesia via epidural catheter (Ropivacaine 0.15% with double initial bolus and subsequent continuous infusion 5 ml/h via elastomeric pump)\n* 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) In addition, both groups will be administered intravenous analgesia at predetermined times: 1 g of paracetamol QID (quater in day, except for patients \\<50 kg and/or with risk factors for hepatotoxicity in which it will be administered in a total dose of 3 g/day), 600 mg of ibuprofen BID (bis in day) and 2 g of MgSO4 TID (tris in day).\n\nPain symptoms will be assessed according to the NRS scale. This system involves the direct evaluation by the patient of the degree of pain perceived on a scale ranging from 0 (no pain) to 10 (worst possible pain). In our study we will consider values greater than or equal to 4 to be unacceptable. In this case, rescue therapy with opioids is envisaged in addition to the intravenous therapy normally administered. The opioid of choice for our protocol is intravenous morphine, administered in boluses at a dosage of 2 mg, repeatable every 15 minutes (= max 8 mg in one hour) until pain symptoms improve with NRS\\<4 or appearance of side effects, considering a maximum daily dose of 50 mg.\n\nData collection\n\nThe following variables will be collected from the medical records, which will then be pseudonymised and inserted into a database to be adequately analysed:\n\n1. Pre-operative:\n\n 1. Anthropometric parameters (age, sex, BMI)\n 2. ASA class\n 3. Revised Cardiac Risk Index\n 4. METS\n 5. Major comorbidities:\n\n i) Diabetes mellitus (DM) ii) Ischemic heart disease (IC) iii) Heart failure (HFS) iv) Chronic obstructive pulmonary disease (COPD) v) Chronic kidney disease (CKD) vi) Other significant pathologies\n2. Intra-operative:\n\n a) Type of surgical procedure i) aortobisiliac repair (AO-BIS) ii) aorto-bifemoral repair (AO-BIF) iii) aorto-aortic (AO-AO) repair b) Surgical time c) Time and type of aortic clamping d) Hemodynamic parameters and events i) Maximum dosage of Norepinephrine (mcg/kg/min) ii) MAP ≤ 65 mmHg iii) FloTrac: CI ≤ 2 L/min and/or SVV \\> 13% iv) Water balance v) Total transfusions in ml (exogenous + blood recovery) vi) Intraoperative AAII thrombotic complications\n3. Post-operative:\n\n a) Pain (NRS scale) both at rest ("static") and upon coughing ("dynamic") i) upon awakening (T0) ii) 2, 4, 8, 12, 18, 24, 30, 36 hours after waking up b) Total dose of rescue opioid c) Occurrence of complications related to the operation and/or the patient\'s comorbidities i) Re-intervention ii) Thrombosis AAII iii) Hemorrhage iv) major cardiac complications (ACS, ACC, arrhythmias) v) infectious complications (wound infection, sepsis, septic shock) vi) pulmonary complications (pneumonia, respiratory failure, pulmonary edema) vii) acute renal failure d) Occurrence of complications related to the therapy administered i) Nausea/vomiting from opioid consumption ii) Failure of the analgesic technique (uncontrolled pain) iii) Hypotension treatable with max norepinephrine base 0.1 mcg/kg/min iv) Hypotension not treatable without higher doses of basic norepinephrine v) Paresthesia of lower limbs vi) Motor deficit of lower limbs vii) Other complications of AE: direct neurological damage, dural puncture headache, subarachnoid injection/spinal anesthesia, urinary retention, low back pain, epidural hematoma, infection, drug allergy, AL absorption viii) Other complications of RSB: infections, fascial hematoma, drug allergy, AL absorption The analysis continues for a total period of 36 hours after waking up in the Intensive Care Unit. The length of in-hospital stay will be also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (age \\> 18 years)\n* patients who have given their consent to participate in the study\n* patients undergoing elective "open" surgical treatment of an abdominal aortic aneurysm with a midline xipho-pubic incision.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients being treated for chronic pain\n* Known allergy to drugs included in analgesia protocols\n* Contraindications to the use of one of the two methods provided:\n\n * refusal by the patient\n * infection at the puncture site\n * coagulopathy:\n\n 1. PTT \\> 40 s and/or INR \\> 1.4\n 2. platelet count \\< 50,000/µL\n 3. taking antiplatelet or anticoagulant drugs that have not been discontinued in good time, according to international guidelines\n* Emergent intervention\n* Lack of consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT06244732', 'acronym': 'POPEYE', 'briefTitle': 'Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Post-Operative Pain Control After Aortic EndoaneurYsmEctomy', 'orgStudyIdInfo': {'id': 'POPEYE_CET 131-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSB', 'description': '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)', 'interventionNames': ['Procedure: Postoperative pain control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EA', 'description': '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)', 'interventionNames': ['Procedure: Postoperative pain control']}], 'interventions': [{'name': 'Postoperative pain control', 'type': 'PROCEDURE', 'description': 'Postoperative analgesia after OR-AAA', 'armGroupLabels': ['EA', 'RSB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Mazzaccaro, MD, PhD', 'role': 'CONTACT', 'email': 'daniela.mazzaccaro@grupposandonato.it', 'phone': '+ 39 025277', 'phoneExt': '4341'}, {'name': 'Gianluca Spinelli, MD', 'role': 'CONTACT', 'email': 'gianluca.spinelli@grupposandonato.it'}], 'facility': 'I.R.C.C.S. Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'centralContacts': [{'name': 'Mattia Ricotti', 'role': 'CONTACT', 'email': 'mattia.ricotti@grupposandonato.it', 'phone': '+390252774236'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Investigator, Vascular Surgeon', 'investigatorFullName': 'Daniela Mazzaccaro', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}