Status:

UNKNOWN

Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery

Lead Sponsor:

Centre Hospitalier Universitaire de Besancon

Conditions:

Aortic Aneurysm, Abdominal

Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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...

Detailed Description

The open repair of abdominal aortic aneurysm (AAA) is a painful surgery. Patients suffering from AAA are at high risk of perioperative cardiovascular and pulmonary complications. It has been previousl...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2019

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT02292667

Start Date

January 1 2015

End Date

January 1 2019

Last Update

August 12 2016

Active Locations (1)

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1

CHU Besançon

Besançon, Doubs, France, 25000