Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneu… (NCT02292667) | Clinical Trial Compass
UnknownPhase 3
Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery
France60 participantsStarted 2015-01
Plain-language summary
The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP study is a single-center open-label randomized controlled trial. Half of patients included will receive the association of TAP block and multimodal intravenous analgesia, and the other half will receive the multimodal intravenous analgesia alone. The multimodal intravenous analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with morphine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ASA (American Society of Anesthesiologists) physical status 1, 2 or 3
* Elective surgery for open repair of an aortic abdominal aneurysm performed in the Vascular Surgery Unit of the University Hospital of Besancon
* Informed consent given
* Health medical insurance affiliation
Exclusion Criteria:
* Poor adherence to protocol attended
* Incapacity to consent
* Pregnancy and/or breast feeding
* Endovascular repair of aortic abdominal aneurysm
* Emergent surgery of a rupture or a fissuration of aortic abdominal aneurysm
* Chronic medical treatment by clopidogrel if clopidogrel not stopped 5 days before surgery at least
* Chronic medical treatment by prasugrel if prasugrel not stopped 7 days before surgery at least
* Chronic medical treatment by ticlopidine, inhibitors of phosphodiesterase , inhibitors of glycoprotein IIb/IIIa, adenosine triphosphate analogs or thrombin receptor antagonists
* Congenital or acquired bleeding disorder
* Incapacity to use patient-controlled analgesia device
* Chronic opioid abuse or dependence
* Chronic renal failure defined as a clearance \< 30 ml/min
* Severe hepatic failure
* Other contraindications to ropivacaïne (allergy, medical history of porphyria, hypovolemia)
* Contraindications to acetaminophen
* Contraindications to morphine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Morphine consumption during the first postoperative 24 hours
Timeframe: 24 hours
Trial details
NCT IDNCT02292667
SponsorCentre Hospitalier Universitaire de Besancon