Informations générales (source: ClinicalTrials.gov)
Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery (ETAP)
Interventional
Phase 3
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
janvier 2015
janvier 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Besançon - 25000 - Besançon - Doubs - France | Julien Chenet, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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